Pharma

Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine

The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.  

By Jonathan Gardner • May 07, 2021

Pharma erupts as Biden administration backs waiver of vaccine patent rights

The shift in U.S. policy might not undermine future research as the drug industry claims. Easing patent protections, though, isn't likely to translate to an immediate boost in vaccine supply.

By Jonathan Gardner , Ned Pagliarulo • May 06, 2021

Pfizer forecasts $26B in coronavirus vaccine revenue this year

The sum is $11 billion higher than Pfizer had estimated in February and, if realized, would make the vaccine the highest grossing pharmaceutical product by revenue in a single year.

By Ned Pagliarulo • May 04, 2021

FDA faces tough choice after panel backs speedy cancer drug approvals

FDA advisers last week recommended maintaining four of six accelerated immunotherapy approvals despite negative results in confirmatory testing.

By Ben Fidler , Ned Pagliarulo • April 30, 2021

Denying problems, AstraZeneca says US coronavirus vaccine filing due within weeks

Five weeks after AstraZeneca reported positive trial results, the company has still not applied to the FDA for authorization, saying the size of the dataset has slowed its submission.

By Jonathan Gardner • April 30, 2021

Merck, GSK vaccine sales hit by pandemic as competitors' business booms

Both companies blamed the impact of COVID-19 on sharp declines in sales of their shingles, pneumonia and HPV shots. 

By Ned Pagliarulo • April 29, 2021

Pfizer buys infectious disease biotech Amplyx

The deal is another sign of Pfizer's interest in infectious disease beyond COVID-19, following the pharma's participation in an industry investment fund.

By Kristin Jensen • April 28, 2021

Lilly, citing FDA feedback, won't seek speedy approval of Alzheimer's drug

The drugmaker confirmed it won't try for accelerated approval of a closely watched Alzheimer's medicine based on a single Phase 2 trial. But it's planning a lengthy new study in presymptomatic patients. 

By Jonathan Gardner • April 27, 2021

Gilead, Merck to help India access COVID-19 drugs as country's crisis deepens

Gilead will donate at least 450,000 vials of Veklury, while Merck licensed its experimental antiviral molnupiravir to five generic drugmakers in India. 

By Ned Pagliarulo • April 27, 2021

Sanofi to aid Moderna on final steps in manufacturing coronavirus vaccine

The French pharma has agreed to "fill and finish" up to 200 million vials of Moderna's shot at its New Jersey plant, the third such manufacturing deal it struck with other vaccine developers. 

By Ned Pagliarulo • April 26, 2021

GSK immunotherapy wins FDA approval, joining crowded cancer drug class

Jemperli is the seventh drug cleared by the FDA that blocks either PD-1 or PD-L1 proteins, joining Merck's Keytruda, Bristol Myers' Opdivo and others.

By Ned Pagliarulo • April 23, 2021

FDA cites Emergent for failings at plant that contaminated J&J doses

A recent nine-day inspection by agency officials found numerous breaches of manufacturing standards and inadequate training for factory employees. 

By Ned Pagliarulo • April 22, 2021

Lilly to seek first approval of an autoimmune drug for hair loss

Two Phase 3 trials have now shown that Lilly's autoimmune drug baricitinib may effectively treat alopecia areata. But the FDA's concerns with so-called JAK inhibitors could complicate a review. 

By Kristin Jensen • April 21, 2021

The next 2 months in biotech and pharma will be busy. Here's what to watch.

New developments could come soon for two coronavirus vaccines while, a bit further off, the fate of Biogen's Alzheimer's drug hangs in the balance. Important data are expected, too, for Vertex and Sarepta.

By Ben Fidler , Ned Pagliarulo , Jacob Bell • April 20, 2021

J&J to resume vaccine rollout in Europe after regulator says benefits outweigh risks

The EMA, however, recommended a warning be added to highlight a rare but serious side effect. Regulators in the U.S. are expected to soon make a similar decision.

By Ben Fidler , Jonathan Gardner • UPDATED: April 20, 2021 at 2:39 p.m.

US clears AstraZeneca buyout of Alexion amid closer scrutiny of biopharma M&A

FTC authorization of the $39 billion deal — the sector's largest in 2020 — may ease concerns over the agency's plans to more intently inspect pharma deals. 

By Jonathan Gardner • April 16, 2021

GSK stops studies testing closely watched cancer immunotherapy

The British pharma will halt enrollment in two studies testing feladilimab alongside Merck's Keytruda, dealing another blow to the company's cancer drug pipeline.

By Ned Pagliarulo • April 15, 2021

Merck, in latest COVID-19 setback, scraps one drug and pins hopes on another

The decision to end development of a medicine acquired in a $425 million deal last November is another disappointment for Merck's coronavirus effort, which once involved multiple drugs and vaccines.

By Ben Fidler • April 15, 2021

CDC panel delays decision on J&J vaccine, extending pause over rare side effect

Advisers to the agency agreed to wait for more data before recommending new guidance, but aim to reconvene quickly to decide whether vaccinations with J&J's shot should be resumed, and for whom.

By Jonathan Gardner • April 14, 2021

The US paused use of J&J's vaccine. What happens next?

A call by regulators to stop J&J vaccinations won't dramatically disrupt supply in the U.S. But changes in labeling are possible, as is a renewed debate over vaccine hesitancy.

By Ned Pagliarulo , Ben Fidler , Jonathan Gardner • April 13, 2021

Sanofi buys an mRNA startup in another bet on 'off-the-shelf' cell therapy

Tidal Therapeutics is the second biotech developing more convenient cell therapies that the French pharma has recently acquired as part of a broader expansion in oncology.

By Ben Fidler • April 09, 2021

With new data, Merck could be first to bring immunotherapy to early kidney cancer

Keytruda has become the first drug of its kind to succeed in the so-called adjuvant setting in renal cell carcinoma, continuing an industry-wide push to establish immunotherapy in earlier lines of cancer care.

By Ben Fidler • April 08, 2021

FDA pushes back decisions on skin disease and arthritis drugs from Pfizer, Lilly

The delays offer further evidence regulators remain wary of the safety issues surrounding so-called JAK drugs like Pfizer's Xeljanz and Lilly's Olumiant.

By Kristin Jensen • April 07, 2021

AstraZeneca's coronavirus vaccine possibly linked to rare blood clots, EMA says

Europe's drug regulator affirmed the benefits of vaccination outweigh the risks, but recommended the shot's label be updated to warn of the newly established side effect.

By Ben Fidler • UPDATED: April 7, 2021 at 12:31 p.m.

Takeda, CSL to end alliance as plasma-based COVID-19 drug fails key test

An unusual partnership to develop a standardized plasma therapy for COVID-19 didn't succeed, but could be a model for collaborations should another public health crisis arise, the drugmakers said.

By Ben Fidler • April 05, 2021