In historic decision, FDA clears coronavirus vaccine from Pfizer, BioNTech

The vaccine was the first authorized for emergency use in the U.S. after a large study showed it to be highly protective against COVID-19, a landmark moment amid a worsening pandemic.

By Jonathan Gardner • Dec. 11, 2020

Viatris to lay off staff, shutter plants in major restructuring

The company created by a merger of Mylan and Pfizer's Upjohn unit is dramatically cutting costs, shedding jobs and closing or divesting up to 15 plants worldwide. 

By Ned Pagliarulo • Dec. 11, 2020

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Top 5 stories from BioPharma Dive

Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.

By BioPharma Dive staff

Sanofi, GSK coronavirus vaccine delayed after early study disappoints

The experimental shot produced a weak immune response in adults over 49, leading the partner drugmakers to change plans and push back their development timelines.

By Ben Fidler • Dec. 11, 2020

Boehringer goes after antibody cancer drugs in latest acquisition

For about $1.4 billion, Boehringer will take control of NBE-Therapeutics and its antibody drug conjugate technology, which has already produced one clinical-stage therapy.

By Kristin Jensen • Dec. 10, 2020

Lilly to pit Loxo cancer drug against top-selling rival after strong study results

Following positive data at ASH, Lilly will test a drug it acquired in last year's buyout of Loxo Oncology against Imbruvica, one of the world's best-selling cancer treatments.

By Ned Pagliarulo • Dec. 7, 2020

Solving supply chain volatility

Supply chain management technologies help monitor shifting demand patterns and ensure life-saving medications reach people quickly and at manageable costs.

By Mandar Paralkar, Global Head of Life Sciences at SAP • Dec. 7, 2020

J&J study finds multiple myeloma cell therapy to be strongly effective

Safety issues that have dogged the CAR-T field remain, however, with the drugmaker reporting some severe side effects, including several that led to patient deaths.

By Jonathan Gardner • Dec. 5, 2020

Lilly, UnitedHealth explore how to best use a COVID-19 antibody drug

A new real-world study will focus on in-home testing and administration of Lilly's bamlanivimab, which was recently cleared for emergency use in certain patients infected with the coronavirus.

By Jacob Bell • Dec. 4, 2020

US buys another 650,000 doses of Lilly's COVID-19 drug as outbreak surges

The U.S. government has ramped up spending on Lilly's and Regeneron's antibody-based COVID-19 treatments, but each remain in short supply.

By Kristin Jensen • Dec. 3, 2020

UK drug regulator is first to clear Pfizer, BioNTech's coronavirus vaccine

The approval is a notable milestone in the historic pursuit of a protective shot for COVID-19. The two drugmakers plan to ship the first doses within days.

By Jonathan Gardner • Dec. 2, 2020

FAA says first flight shipping coronavirus vaccine takes off

With two experimental shots now undergoing FDA review, airports and shipping companies are readying for the mass shipment of vaccine doses.

By Matt Leonard • Nov. 30, 2020

A closer look at the behind-the-scenes companies moving coronavirus vaccines around the world

Freight forwarders, the linchpins of the supply chain, face the daunting task of ensuring hundreds of millions of doses make the journey from factory to clinic.

By Deborah Abrams Kaplan • Nov. 30, 2020

Merck, expanding coronavirus work, buys a small biotech and its COVID-19 drug

The large drugmaker will pay $425 million to acquire OncoImmune, which is developing a treatment for severe coronavirus disease. 

By Ned Pagliarulo • Nov. 23, 2020

AstraZeneca, Oxford vaccine prevents COVID-19, though study results raise questions

Data from two late-stage trials showed the shot to be, on average, 70% effective against COVID-19 — an encouraging finding. The lower dose tested, however, unexpectedly outperformed a higher dose.

By Ben Fidler • Updated Nov. 23, 2020

WHO recommends against Gilead's Veklury, in break with US guidelines

The organization argues there's no evidence the antiviral saves lives or improves outcomes for COVID-19 patients, despite positive data on the latter point from a key U.S. study.

By Jonathan Gardner • Nov. 20, 2020

Lilly dives into gene editing

Through a deal with Precision Biosciences, the pharma aims to develop therapies for genetic disorders, including Duchenne muscular dystrophy.

By Jacob Bell • Nov. 20, 2020

Hospitals scramble to get ready for coronavirus vaccines

Facilities are preparing ultra-cold storage capabilities and reviewing security plans as they brace for their role in distributing potentially multiple shots.

By Shannon Muchmore • Nov. 19, 2020

New AstraZeneca data offer latest hint coronavirus vaccines may protect elderly

Results published Thursday add to hopes the experimental shots now in testing won't only work for young, healthy people. More details are needed, though.

By Ben Fidler • Nov. 19, 2020

Pfizer strikes a deal with newly formed China biotech

The deal, which has Pfizer paying as much as $70 million, is the latest in a series of moves by big pharma companies to forge a stronger position in the world's second-largest drug market.

By Kristin Jensen • Nov. 19, 2020

New coronavirus vaccine data bolster Pfizer, BioNTech claims of strongly effective shot

Reaching the main goal of their large trial, Pfizer and BioNTech reported 162 cases of COVID-19 among participants who received a placebo, and just eight for those who were vaccinated. 

By Ned Pagliarulo • Nov. 18, 2020

FDA delays decision on Bristol Myers cell therapy, putting Celgene deal payouts in jeopardy

Travel restrictions have made it difficult for the regulator to inspect a plant used to make the treatment, meaning the drugmaker could miss a deadline critical to former Celgene shareholders.

By Jonathan Gardner • Nov. 17, 2020

Moderna's vaccine can last for weeks in a refrigerator, expanding an edge on rivals

Pharmacies and doctor's offices should be able to store Moderna's shot on site, a crucial advantage for the mass immunization challenge that lies ahead.

By Jonathan Gardner • Nov. 16, 2020

Lilly backs a biotech's spinout and places a small bet on protein degradation

An alliance with BeyondSpring spinout Seed Therapeutics makes Eli Lilly the latest pharma company to dive into the fast-emerging drug research field. 

By Ben Fidler • Nov. 13, 2020

AstraZeneca cancer drug found ineffective for COVID-19

The setback follows disappointing results from companies like Novartis and Sanofi, which have also sought to repurpose existing drugs for COVID-19.

By Kristin Jensen • Nov. 12, 2020

Pfizer, with vaccine results positive, readies plans to ship coronavirus shot

Twelve trucks and 20 planes would be used each day to distribute the vaccine, should approvals follow Pfizer and partner BioNTech's positive study results. 

By Matt Leonard • Nov. 11, 2020