Tag Archives: drugmakers

Drugmakers rush to test whether vaccines stop coronavirus variant

By John Miller and Patricia Weiss

ZURICH/FRANKFURT (Reuters) – Drug makers including BioNTech and Moderna are scrambling to test their COVID-19 vaccines against the new fast-spreading variant of the virus that is raging in Britain, the latest challenge in the breakneck race to curb the pandemic.

Ugur Sahin, chief executive of Germany’s BioNTech which with partner Pfizer took less than a year to get a vaccine approved, said on Tuesday he needs another two weeks to know if his shot can stop the mutant variant of the virus.

Moderna expects immunity from its vaccine to protect against the variant and is performing more tests in coming weeks to confirm, the company said in a statement to CNN. Moderna did not immediately respond to Reuters’ requests for comment.

The mutation known as the B.1.1.7 lineage may be up to 70% more infectious and more of a concern for children. It has sown chaos in Britain, prompting a wave of travel bans that are disrupting trade with Europe and threatening to further isolate the island country.

Sahin said there are nine mutations on the virus.

While he does not believe any are significant enough to skirt the protection afforded by BioNTech’s mRNA vaccine, which was approved by the European Union on Monday, he said another 14 days or so of study and data collection are needed before offering a definitive answer.

“Scientifically it is highly likely that the immune response by this vaccine can also deal with this virus variant,” he said on a call with reporters.

“The vaccine contains more than 1,270 amino acids, and only 9 of them are changed (in the mutant virus). That means that 99% of the protein is still the same.”

Germany’s CureVac said it does not expect the variant to affect the efficacy of its experimental shot, which is based on the same messenger RNA (mRNA) technology used by Pfizer-BioNTech.

It started late stage clinical trials on its vaccine candidate last week and is constantly reviewing variants, which the company said are common as viruses spread.

Even though there are multiple mutations, BioNTech’s Sahin said, most of the sites on the virus that are recognized by the body’s T-cell response are unchanged, and multiple antibody binding sites are also conserved.

MRNA ADVANTAGE

In the event that the variant presents vaccine developers with an unexpected challenge, an advantage of mRNA is that scientists can quickly re-engineer genetic material in the shot to match that of the mutated protein, whereas modifying traditional vaccines would require extra steps.

“In principle, the beauty of the mRNA technology is we can directly start to engineer a vaccine which completely mimics this new mutation,” Sahin said.

“We could be able to provide a new vaccine technically within six weeks. Of course, this is not only a technical question. We have to deal with how regulators… would see that.”

Britain’s chief scientific adviser Patrick Vallance said on Saturday vaccines appeared to be adequate in generating an immune response to the variant of the coronavirus.

The World Health Organization (WHO) said on Tuesday it will convene a meeting of members to discuss strategies to counter the mutation.

Q&A: Where are we in the COVID-19 vaccine race?

(Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over 1.26 million lives worldwide:

Who is furthest along?

U.S. drugmaker Pfizer Inc and German partner BioNTech SE were the first to release data showing on Monday that their vaccine worked in a large, late-stage clinical trial.

Russia’s sovereign wealth fund published interim late-stage trial results for its Sputnik V vaccine on Wednesday showing the shot is 92% effective at protecting people from COVID-19.

The next data releases will likely be from U.S. biotech firm Moderna Inc, possibly in November, and from Britain-based AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

Why is Pfizer ahead with its data?

The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.

Pfizer said its interim analysis was conducted after 94 participants in the trial developed COVID-19 while Russia’s examination was conducted after 20 participants in the trial developed the disease.

AstraZeneca said last week a slowdown in infections during the summer is delaying data analysis for its UK trial.

COVID-19 cases, however, soared in October and early November, setting daily records in the United States and Europe.

How well are the vaccines supposed to work?

The World Health Organization has recommended a minimum standard for effectiveness of at least 50%. The United States and some other regulators are following that guideline – which means there must be at least twice as many infections among volunteers who received a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.

Pfizer and Russia both said their vaccines are more than 90% effective against COVID-19.

When will regulators rule on safety and efficacy?

Regulators review vaccines after companies submit applications seeking either emergency use authorization (EUA) or formal approval.

The earliest the U.S. Food and Drug Administration could make a decision is in December because Pfizer/BioNTech and Moderna do not expect to have enough safety data until the second half of November. The FDA has asked companies to watch trial participants for side effects for two months after receiving a final vaccine dose.

Regulators for Europe, the United Kingdom and Canada are considering data on a rolling basis, as it becomes available. They expect to conduct expedited reviews as well. It is not clear when companies will submit efficacy data to these agencies or when the agencies would make a decision.

Could these be the first widely available coronavirus vaccines?

Yes, although China is on a similar timeline. The country launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people.

At least four vaccines are far along including those from China National Biotec Group (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November.

Russia has also given the Sputnik V vaccine developed by the Gamaleya Institute to 10,000 members of the general population considered at high risk of contracting the virus.

In late October, the director of the Gamaleya Institute, Alexander Gintsburg, said 20,000 volunteers had received the first shot so far and 9,000 the second.

(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanova in Moscow; Editing by Caroline Humer, Bill Berkrot, Edwina Gibbs, David Clarke and Josephine Mason)

Q&A: Where are we in the COVID-19 vaccine race?

By Carl O’Donnell

NEW YORK (Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

As some companies close in on unveiling their initial findings – with Canadian and European regulators already reviewing early data on some vaccines – the following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives:

Who is furthest along?

U.S. drugmaker Pfizer Inc with German partner BioNTech SE, U.S. biotech Moderna Inc and Britain-based AstraZeneca Plc in conjunction with University of Oxford researchers could provide early analyses of data from their various large trials as early as October or November. Johnson & Johnson is a bit further behind.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot. Neither trial participants nor researchers know who has received the vaccine or placebo until the data is ready for review, or unblinded. The studies rely on subjects becoming naturally infected with COVID-19, so how long it takes to generate results largely depends on how pervasive the virus is where the trials are being conducted. In areas with large outbreaks and community spread, infections will pile up faster.

How will we know if the vaccine works?

The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Vaccines must demonstrate at least 50% efficacy – meaning at least twice as many infections among volunteers who got a placebo as among those in the vaccine group. Independent panels oversee the trials to monitor for safety and effectiveness since the data is hidden from companies and researchers. These data safety monitoring boards take a peek at the interim results at pre-determined milestones, such as after a certain number of people have become infected. If the vaccine is looking significantly better than the placebo, the companies can apply for emergency use, and the study may be halted or continue to its intended conclusion. A trial can also be halted if the panel determines the vaccine to be unsafe.

Will regulators ensure a vaccine is safe before making it available to the public?

The U.S. Food and Drug Administration has said it will not approve a vaccine unless it is both effective and safe. Earlier this month, it added more stringent safety guidelines for U.S. vaccines. The FDA wants developers to follow trial subjects for at least two months after they receive their final vaccine dose to check for any side effects that may crop up. The agency will consider an emergency use authorization (EUA) once that data is collected from at least half of the trial’s participants. The UK Medicines and Healthcare products Regulatory Agency will review the vaccines for the UK and the European Medicines Agency will review vaccines for European Union use.

When will regulators decide?

Regulators will review the vaccines after the companies have enough data to submit applications seeking an EUA or formal approval. Moderna’s first look at data is more likely to come next month. AstraZeneca could provide a look at late-stage data in November. Pfizer/BioNtech said it may have data as early as October, but that it would wait for safety data it expects in the third week of November to file with U.S. regulators.

Regulators for Europe and Canada are considering data on a rolling basis, as it becomes available. The UK and the United States both expect speedy reviews of initial data for possible emergency use before more traditional lengthy reviews for formal commercial approvals.

Could these be the first approved coronavirus vaccines?

Yes, although China and Russia are on a similar timeline. China launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four vaccines are far along including from China National Biotec Group [CHNAPF.UL] (CNBG), CanSino Biologics <6185.HK> and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November. Russia’s Gamaleya Institute has begun a 40,000-person late-stage trial and is expected to have early data at the end of October or early November. Russia has also given the vaccine to at least hundreds of “high-risk” members of the general population.

Is U.S. authorization up to President Trump?

The FDA must make sure that the benefits of a vaccine outweigh the risks before authorization since they are intended to be given to hundreds of millions of healthy people. However, the U.S. Department of Health and Human Services (HHS) has the authority to override the FDA’s recommendation. President Donald Trump has complained about the new safety guidelines, which delay any vaccine availability until after the Nov. 3 presidential election at the earliest. The Trump administration can hire and fire HHS officials, opening the possibility of political pressure to approve a vaccine.

(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanovo in Moscow; Editing by Caroline Humer, Bill Berkrot and Frances Kerry)

As globe gallops into vaccine trials, insurers remain unfazed

By Noor Zainab Hussain, Carolyn Cohn and Ludwig Burger

LONDON/FRANKFURT (Reuters) – The world is racing towards a vaccine in record time, stirring public concerns about safety to the extent that nine leading developers have felt compelled to issue a pledge to uphold scientific standards and testing rigor.

Yet, while more than 40 experimental COVID-19 vaccines are being tested on humans, the insurance companies with decades of experience in assessing the risks of clinical trials don’t see anything to be unduly concerned about.

Executives at insurer Allianz and brokers Gallagher and Marsh, among the leading players in clinical trials insurance, told Reuters that premiums had only marginally increased so far in the current pandemic.

They argued there was little structural difference to trials carried out in the past, despite drugmakers around the world competing to shatter the fastest time in history for developing a vaccine, which stands at around four years.

“Rates have been relatively stable. Even this year we have so far seen only moderate price increases on average, with higher price jumps for particularly exposed COVID-19 trials,” said Mark Piazzi, senior underwriter liability at Allianz Global Corporate & Specialty.

This was echoed by David Briggs, managing director, life sciences practice at Gallagher, who said every trial was rated on its methods and the kinds of patients involved.

Gallagher said premiums in Britain, for example, started at about 5,000 pounds ($6,500) per trial.

Total claims limits in policies were typically set at roughly $6-12 million, depending on the country’s rules, according to several insurance companies interviewed by Reuters.

In Britain, for instance, claim limits were usually set at no lower than 5 million pounds, while in Germany the figure was around 10 million euros ($11.8 million).

‘LOSS EXPERIENCE NOT DRAMATIC’

However part of the reason why premiums have not risen as sharply as some people might have expected is that claims from trial are generally uncommon, according to executives. This is because patients have often signed so-called informed consent agreements, they said.

Jim Walters, managing director of Life Sciences & Chemical Group at broker Aon, said such agreements outlined the risks that patients were taking by participating in the trial.

“So, you know, everything from you could have a sore spot on your arm. To you could potentially die. And you know, they would literally go that far in some of these protocols,” he added.

“Those generally tend to hold up in courts and in legal systems around the world. That means that the loss experience coming out of clinical trials is not very dramatic.”

Claims are often limited to circumstances linked to the improper conduct of trials or any wrongdoing, rather than side-effects of the treatment, executives said.

Such have been the worries about the vaccine race among some members of the public, who fear safety standards could slip, that nine developers issued a joint pledge last month to “uphold the integrity of the scientific process”.

ASTRAZENECA TRIAL SUSPENSION

AstraZeneca and Oxford University’s suspension of global Phase III trials of their experimental COVID-19 vaccine early last month due to a participant’s illness brought the risk of side effects in clinical trials to the public fore.

But the insurers said such delays were not unexpected, and could even reflect the extra caution of vaccine developers given the lack of data about COVID-19.

“Side effects always happen with clinical trials, but these are typically mild and expected. It is not very common to delay or suspend trials, it does happen though,” said Piazzi at AGCS, whose main peers in underwriting trials include Chubb, HDI and Fairfax’s Newline.

“Pharma companies and insurers alike are even more careful than usual with COVID-19 trials because there is so much at stake, particularly for the patients’ safety.”

All trials of the vaccine candidate have resumed, with the exception of the U.S. study.

There have been examples in recent memory of drug trials going catastrophically wrong, though.

In 2016, for instance, one participant died and five were hospitalized in a Phase I trial run by French company Biotrial in the city of Rennes, testing an experimental mood brightener made by Portuguese drugmaker Bial.

In 2006, six patients required intensive care after receiving a potential treatment against leukemia and auto-immune disease in London. One was described as looking like “the elephant man” after his head swelled. Another lost fingertips and toes. Germany’s TeGenero, the initial developer of the medicine, folded.

But insurance executives stress such disasters are rare, given the thousands of clinical drug trials being carried out every year.

Walters of Aon, speaking about the 2016 trial, said it was “obviously a horrible situation”.

“But that’s one of very few incidents of really bad loss experience that the industry has faced. So, clinical trial insurance is not hugely expensive. Let’s put it that way.”

(Reporting by Noor Zainab Hussain, Carolyn Cohn and Ludwig Burger; Editing by Pravin Char)

Explainer: When will COVID-19 vaccines be generally available in the U.S.?

By Carl O’Donnell and Michael Erman

(Reuters) – U.S. President Donald Trump and the head of the Centers for Disease Control and Prevention (CDC) this week disagreed about when a COVID-19 vaccine would become widely available. Trump has said one could initially be available by the Nov. 3 election, while the CDC director said vaccines were likely to reach the general public around mid-2021, an assessment more in line with most experts.

WHAT DOES IT MEAN FOR A VACCINE TO BE GENERALLY AVAILABLE?

General availability is when every American who wants the vaccine can get it. There are currently no COVID-19 vaccines approved by U.S. regulators, although a handful are in late-stage trials to prove they are safe and effective.

Experts estimate that at least 70% of roughly 330 million Americans would need to be immune through a vaccine or prior infection to achieve what is known as herd immunity, which occurs when enough people are immune to prevent the spread of the virus to those unable to get a vaccine.

HOW LONG BEFORE VACCINE PRODUCTION IS FULLY RAMPED UP?

Most vaccines in development will require two doses per person.

The CDC anticipates that 35 million to 45 million doses of vaccines from the first two companies to receive authorization will be available in the United States by the end of this year. The current front runners are Pfizer Inc and Moderna Inc.

Drugmakers have been more ambitious with their calculations. AstraZeneca Plc has said it could deliver as many as 300 million doses of its experimental vaccine in the United States by as early as October. Pfizer and German partner BioNTech SE have said they expect to have 100 million doses available worldwide by the end of 2020, but did not specify how much of that was earmarked for the United States. Moderna on Friday said it is on track to make around 20 million doses by the end of the year and between 500 million and 1 billion doses a year beginning in 2021.

Obtaining enough doses to inoculate everyone in the United States will likely take until later in 2021. CDC Director Robert Redfield told a congressional hearing on Wednesday that vaccines may not be widely available to everyone in the United States until the second or third quarter of next year.

WHO WOULD GET AN APPROVED VACCINE FIRST?

The CDC decision will likely broadly follow recommendations from the National Academies of Sciences, Engineering and Medicine. The CDC has said the earliest inoculations may go to healthcare workers, people at increased risk for severe COVID-19, and essential workers.

It is unclear when a vaccine will be available for children as major drugmakers have yet to include them in late-stage trials. Pfizer and BioNTech have filed with regulators seeking to start recruiting volunteers as young as 16 for vaccine studies.

WHICH COMPANIES WILL LIKELY ROLL OUT A VACCINE QUICKLY?

Pfizer has said it could have compelling evidence that its vaccine works by the end of October. Moderna says it could have similar evidence in November. The vaccines would first need to be approved or authorized for emergency use by U.S. regulators.

Drugmakers have already started manufacturing supplies of their vaccine candidates to be ready as soon as they get the go ahead. The U.S. Department of Defense and the CDC plan to start distribution of vaccines within 24 hours of regulatory authorization.

Several drugmakers including Pfizer, AstraZeneca, Johnson & Johnson and Novavax Inc have all said they expect to produce at least 1 billion doses of their vaccines next year if they get regulatory authorization.

Sanofi SA and GlaxoSmithKline Plc are also working on developing a vaccine they say could be authorized next year.

(Reporting by Carl O’Donnell and Michael Erman in New York; additional reporting by Caroline Humer; editing by Peter Henderson and Bill Berkrot)

Drugmakers slash prices to win China’s bulk-buy contracts: state media

BEIJING/SHANGHAI (Reuters) – Drugmakers have slashed prices by up to 95% to win state contracts in China’s largest bidding round of its drug procurement program, state media said on Thursday.

Beijing has implemented a national scheme where global pharmaceutical companies and Chinese generic drugmakers vie to sell their products in bulk at public hospitals.

In the latest bidding round for contracts worth hundreds of billions yuan in total, drugmakers cut prices by 53% on average, state media Xinhua reported, citing preliminary results.

It involves 55 types of medicines, more than the previous two rounds.

Drugs open for bidding covered some products that contributed more than $1 billion each to foreign drugmakers’ sales in 2019 but face challenges from generic versions offered by local drugmakers.

They included AstraZeneca Plc’s heart disease treatment Brilinta, and blood-thinner Eliquis, jointly developed by Pfizer Inc. and Bristol Myers Squibb Co (BMS). Contracts for the two treatments were won by Chinese companies, according to preliminary results published by procurement authorities.

A BMS representative said that the company decided not to join the bidding for Eliquis, and that it will speed up introducing new drugs in China.

AstraZeneca did not reply to a Reuters request for comment.

Foreign companies generally quoted higher prices in Thursday’s bidding and barely secured any contracts, said ICBC International Research analyst Zhang Jialin.

More expensive brand-name drugs still had opportunities in the market not covered by the national procurement scheme, thanks to their higher profile among patients and doctors compared with cheaper generic drugs, Zhang said.

Thursday’s bidding also showed China’s generic drugs market starting to concentrate around a few big players, Zhang added.

Units of Shanghai Pharmaceuticals Holding won bids for six products, the parent company said in a filing.

For smaller firms, the bulk-buy scheme might risk driving them close to losses, said Wang Yue, a professor at Peking University’s School of Health Humanities.

“Many companies actually have no power to bargain with the government,” he said. “When the market changes, like when labor and logistics costs rise, the (low drug) prices are hard to sustain.”

For most products in Thursday’s bidding, if a single company won the bid, it could provide up to half of the total procurement volume in the first year. If there were at least four winners, 70-80% of the volume could be shared, procurement authorities said in official guidance last month.

(Reporting by Roxanne Liu in Beijing and Brenda Goh in Shanghai; Editing by Nick Macfie and Mark Potter)

Next big COVID-19 treatment may be manufactured antibodies

By Deena Beasley

(Reuters) – As the world awaits a COVID-19 vaccine, the next big advance in battling the pandemic could come from a class of biotech therapies widely used against cancer and other disorders – antibodies designed specifically to attack this new virus.

Development of monoclonal antibodies to target the virus has been endorsed by leading scientists. Anthony Fauci, the top U.S. infectious diseases expert, called them “almost a sure bet” against COVID-19.

When a virus gets past the body’s initial defenses, a more specific response kicks in, triggering production of cells that target the invader. These include antibodies that recognize and lock onto a virus, preventing the infection from spreading.

Monoclonal antibodies – grown in bioreactor vats – are copies of these naturally-occurring proteins.

Scientists are still working out the exact role of neutralizing antibodies in recovery from COVID-19, but drugmakers are confident that the right antibodies or a combination can alter the course of the disease that has claimed more than 675,000 lives globally.

“Antibodies can block infectivity. That is a fact,” Regeneron Pharmaceuticals executive Christos Kyratsous told Reuters.

Regeneron is testing a two-antibody cocktail, which it believes limits the ability of the virus’ to escape better than one, with data on its efficacy expected by late summer or early fall. “Protection will wane over time. Dosing is something we don’t know yet,” said Kyratsous.

The U.S. government in June awarded Regeneron a $450 million supply contract. The company said it can immediately begin production at its U.S. plant if regulators approve the treatment.

Eli Lilly and Co, AstraZeneca, Amgen, and GlaxoSmithKline were cleared by the U.S. government to pool manufacturing resources in order to scale up supplies if any of these drugs prove successful.

Even with that unusual cooperation among rivals, manufacturing these medicines is complex and capacity is limited. There is also a debate over whether a single antibody will be powerful enough to stop COVID-19.

AstraZeneca said it plans to start human trials of its dual-antibody combination within weeks.

Lilly, which began human testing in June of two antibody candidates in separate trials, is focusing on a one-drug approach.

“If you need a higher dosage or more antibodies, fewer people can be treated,” Lilly Chief Scientific Officer Dan Skovronsky said.

‘INSTANT IMMUNITY’

Unlike vaccines, which activate the body’s own immune system, the impact of infused antibodies eventually dissipates.

Still, drugmakers say monoclonal antibodies could temporarily prevent infection in at-risk people such as medical workers and the elderly. They could also be used as a therapeutic bridge until vaccines become widely available.

“In a prophylactic setting we think we may achieve coverage for up to six months,” said Phil Pang, chief medical officer of Vir Biotechnology, which aims to start testing an antibody in non-hospitalized patients next month with partner GSK.

“The advantage of an antibody is that it is basically instant immunity,” said Mark Brunswick, senior vice president at Sorrento Therapeutics, which aims to begin human trials next month of a single antibody candidate.

Safety risks for monoclonal antibodies are considered low, but their cost can be quite high. These type of drugs for cancer can cost over $100,000 a year.

There is also concern that the coronavirus could become resistant to specific antibodies. Researchers are already at work on second-generation compounds with targets other than the crown-like spikes the virus uses to invade cells.

“We are trying to develop something that is complementary,” Amgen research chief David Reese said. Amgen is working with Adaptive Biotechnologies Corp.

Researchers in a recent paper published in the journal Nature said they had discovered several new, very potent, antibodies directed to an area where the virus attaches to human cells and to a region of the spike that has not attracted attention.

“To avoid development of resistance you want to target different sites,” study author and Columbia University professor David Ho told Reuters.

There are also questions about when in the course of the illness it might be best to employ these new weapons.

“Giving an antibody later on after infection might not be that helpful, said Florian Krammer, microbiology professor at New York’s Icahn School of Medicine. “Given early, they probably work well.”

(Reporting By Deena Beasley, editing by Peter Henderson and Bill Berkrot)

U.S. drugmaker stocks fall ahead of Trump’s pricing executive orders

(Reuters) – Shares of U.S. drugmakers fell on Friday, ahead of executive orders by President Donald Trump aimed at lowering drug prices.

With a re-election race underway and the coronavirus pandemic raging in the country, the White House is looking to bring down drug prices by reportedly considering tying them to what consumers outside the United States pay.

The S&P 500 was down 1.3%, with drugmakers such as Regeneron Pharmaceuticals Inc. and Pfizer Inc. weighing on the index. The declines were in line with a fall in broader markets.

Given that the speculation of an executive order on drug pricing surfaced roughly a month ago, stocks in the healthcare sector are unlikely to take a hit in the near term, Jefferies analyst Jared Holz said.

The administration’s move would likely be viewed more as political posturing than a critical moment for the pharmaceutical industry, Holz added.

Trump, who had previously urged lawmakers to rein in drug costs, will deliver remarks and sign the executive orders at 3 p.m. EDT (1900 GMT) on Friday, according to the president’s schedule issued by the White House on Thursday.

Drugmakers often negotiate rebates or discounts on their list prices in exchange for favorable treatment from insurers and other healthcare payers. As a result, insurers and covered patients rarely pay the full list price of a drug.

Elimination of rebates is likely not included in the orders, Politico reported on Thursday.

Such an order would be positive for health insurers UnitedHealth Group Inc, Cigna Corp and CVS Health, said Mizuho analyst Ann Hynes.

Cigna and CVS were among the handful of healthcare movers in the black.

Drugmakers Johnson & Johnson and Merck & Co Inc were trading down in morning trading.

(Reporting by Manas Mishra in Bengaluru; Editing by Shinjini Ganguli)

J&J to begin human trials of COVID-19 vaccine in second half of July

(Reuters) – Johnson & Johnson said on Wednesday it would start human trials of its potential COVID-19 vaccine in the second half of July, two months earlier than planned, as drugmakers race to develop a shot for the deadly respiratory disease.

The company has already signed deals with the U.S. government to create enough manufacturing capacity to produce more than 1 billion doses of its vaccine through 2021.

There are currently no approved treatments or vaccines for COVID-19, the illness caused by the new coronavirus that has killed more than 400,000 people globally.

J&J’s study will test the vaccine against a placebo and assess the shot’s safety and immune response in 1,045 healthy people aged 18 to 55 years, as well as those 65 years and older. The trial will take place in the United States and Belgium.

U.S. biotech Moderna Inc is at the forefront of COVID-19 vaccine development and has started testing its candidate in a mid-stage trial that will enroll 600 patients. The company expects to begin late-stage trials in July.

AstraZeneca, Sanofi, Pfizer and GlaxoSmithKline are all at various stages of development of their vaccine candidates.

There are currently about 10 coronavirus vaccines being tested in humans and experts have predicted that a safe and effective vaccine could take 12 to 18 months from the start of development.

(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Saumyadeb Chakrabarty)

More drugmakers hike U.S. prices as new year begins

By Michael Erman

NEW YORK (Reuters) – Drugmakers including Bristol-Myers Squibb Co, Gilead Sciences Inc, and Biogen Inc hiked U.S. list prices on more than 50 drugs on Wednesday, bringing total New Year’s Day drug price increases to more than 250, according to data analyzed by healthcare research firm 3 Axis Advisors.

Reuters reported on Tuesday that drugmakers including Pfizer Inc, GlaxoSmithKline PLC and Sanofi SA were planning to increase prices on more than 200 drugs in the United States on Jan. 1.

Nearly all of the price increases are below 10% and the median price increase is around 5%, according to 3 Axis.

More early year price increases could still be announced.

Soaring U.S. prescription drug prices are expected to again be a central issue in the presidential election. President Donald Trump, who made bringing them down a core pledge of his 2016 campaign, is running for re-election in 2020.

Many branded drugmakers have pledged to keep their U.S. list price increases below 10% a year, under pressure from politicians and patients.

The United States, which leaves drug pricing to market competition, has higher prices than in other countries where governments directly or indirectly control the costs, making it the world’s most lucrative market for manufacturers.

Drugmakers often negotiate rebates on their list prices in exchange for favorable treatment from healthcare payers. As a result, health insurers and patients rarely pay the full list price of a drug.

Bristol-Myers said in a statement it will not raise list prices on its drugs by more than 6% this year.

The drugmaker raised the price on 10 drugs on Wednesday, including 1.5% price hikes on cancer immunotherapies Opdivo and Yervoy and a 6% increase on its blood thinner Eliquis, all of which bring in billions of dollars in revenue annually.

It also raised the price on Celgene’s flagship multiple myeloma drug, Revlimid, 6%. Bristol acquired rival Celgene in a $74 billion deal last year.

Gilead raised prices on more than 15 drugs including HIV treatments Biktarvy and Truvada less than 5%, according to 3 Axis.

Biogen price increases included a 6% price hike on multiple sclerosis treatment Tecfidera, according to 3 Axis.

Gilead and Biogen could not be immediately reached for comment.

3 Axis advises pharmacy industry groups on identifying inefficiencies in the U.S. drug supply chain and has provided consulting work to hedge fund billionaire John Arnold, a prominent critic of high drug prices.

(Reporting by Michael Erman; Editing by Nick Zieminski)