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AbbVie, Biogen lead pharma in new year's drug price hikes

Average list price increases across the drug industry, however, appear lower than last year, according to one analysis. 

UK authorizes AstraZeneca, Oxford coronavirus vaccine, but questions linger

The first public vaccinations with AstraZeneca and Oxford’s shot are now underway. But it’s still unclear how effective the vaccine is, or the best way to use it.

US pays another $2B to buy more doses of Pfizer, BioNTech coronavirus vaccine

The new deal will provide the U.S. with 100 million additional doses of Pfizer and BioNTech's shot, but the much-needed supply won't be available for several months.

Merck signs $356M deal to supply US with experimental coronavirus drug

The drugmaker spent $425 million a month ago to acquire the biotech developer of the treatment, which tamps down on the body's inflammatory response to viral infections.

Dive Awards

Biotech of the Year: Seagen

A billion-dollar deal with Merck followed quick approvals for the company's second and third drugs, pushing Seagen's market value to over $30 billion.

Vertex teams up with Skyhawk, leaning on another biotech in bid to diversify

Following a string of deals in edgy, unproven fields of scientific research, Vertex's latest deal involves chemical-based drugs that target RNA — an approach that's already attracted several large pharmas.

Amgen's asthma drug takes a hit, making for stiffer competition with Regeneron

Just a month after finding success in a Phase 3 trial, Amgen's tezepelumab has come up short in a different study that some analysts think will give an upper hand to Regeneron's Dupixent.

Changing identity, Agios to sell cancer drug business to Servier

Servier will pay Agios $1.8 billion upfront to acquire the biotech's approved leukemia treatment Tibsovo as well as the rest of its pipeline in cancer and early-stage research work.

Pfizer, BioNTech win EU vaccine approval as UK grapples with new coronavirus variant

In a press conference on the authorization, BioNTech CEO Ugur Sahin expressed confidence the vaccine would protect against the emerging virus variant in the U.K.

FDA grants approval to Ebola drug from Ridgeback

In a landmark study, fewer people given Ebanga died from Ebola virus infection than did those who received a control drug. Results from the trial also led to an OK for Regeneron's drug Inmazeb. 

Trump administration finalizes policy on 'value-based' drug deals

The agency argues the final rule, which takes effect in 2022, will help encourage more reimbursement arrangements that link payment to clinical outcomes.

Cancer case puts UniQure's hemophilia gene therapy on hold, raising alarms

The FDA halted the AMT-061 program, which could be the first approved gene therapy for hemophilia B, because a patient who received the treatment appears to have developed liver cancer.

With biosimilars looming, Roche makes case for new biologic eye drug

Twelve-week dosing for faricimab would help Roche's competitive position, but copycat drugs for existing treatments could soon flood the market.

FDA delays decision on Novartis cholesterol therapy

The regulator declined to approve inclisiran, which Novartis acquired in its buyout of The Medicines Co., after agency staff weren't able to inspect a production facility in Europe.

Moderna's first FDA clearance brings the US a second coronavirus vaccine

The FDA's emergency authorization of the biotech's shot bolstered a nascent immunization campaign in the U.S.

Dive Awards

Researchers of the Year: The RECOVERY team

The U.K.'s RECOVERY trial proved a cheap steroid could keep COVID-19 patients from dying, and showed two other widely considered drugs didn't work — crucial findings in a sprawling, global hunt for coronavirus treatments.

Rollout of Pfizer's coronavirus vaccine hits some speed bumps amid confusion over shipments

Several thousand doses were returned and replaced after getting too cold. Pfizer and the federal government, meanwhile, don't appear to be on the same page for the next wave of shipments. 

Novartis acquires a small biotech and its trio of brain drugs

More active in neuroscience than most pharmaceutical firms, Novartis would gain three experimental drugs for depression, schizophrenia and movement disorders through the deal.

A play-by-play of the FDA meeting on Moderna's coronavirus vaccine

Members of an independent advisory committee voted 20-0 to recommend use of the company's experimental shot, paving the way for an emergency authorization from the FDA.

UPDATED: Dec. 17, 2020 at 5:42 p.m.

FDA panel endorses Moderna's coronavirus vaccine

A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the FDA within days. 

UPDATED: Dec. 17, 2020 at 6:02 p.m.

MacroGenics wins FDA approval of breast cancer drug

Margenza, which bested Roche's Herceptin in a head-to-head study, offers a new option to patients with HER2-positive metastatic breast cancer who have already tried other regimens.

Column

Pharmacquired: What a surprise deal does for AstraZeneca and Alexion

The $39 billion tie-up would hand AstraZeneca five marketed rare disease drugs, including the pricey medicines Soliris and Ultomiris.

With trial plans, Novo wagers its diabetes drug can help treat Alzheimer's

Similar diabetes drugs from Novo have shown signs of promise in treating dementia. The Danish biotech is now putting that hypothesis to the test.

Sage replaces CEO Jonas with Alnylam veteran Greene

With Barry Greene, Sage hands the reins to a respected biotech executive who had success in building a commercial organization at Alnylam.

Gilead hands back some rights to key drug from Galapagos deal

The drug, known as filgotinib, recently hit a setback in the U.S., prompting Gilead to lose confidence that it can gain approval or compete against rival medicines in rheumatoid arthritis.