Gilead breaks through with first approval for new HIV drug

European authorities cleared Gilead’s long-acting shot for patients whose HIV infection is resistant to other drugs. An FDA decision is expected by December.

By Jonathan Gardner • Aug. 22, 2022

Sanofi ends development of breast cancer drug in another blow to pipeline

The French drugmaker’s shares fell by more than 6% after the once promising treatment, called amcenestrant, failed its second major trial this year.

By Kristin Jensen • Aug. 17, 2022

Explore the Trendline➔

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

UK approves Moderna’s two-pronged COVID-19 booster

Britain’s drug regulator is the first public health authority to clear a vaccine designed to fight omicron as well as the original strain of the virus. 

By Jonathan Gardner • Aug. 15, 2022

Novartis bid to repurpose rare disease drug for cancer falls short in third trial

A study testing Novartis’ canakinumab as an adjuvant lung cancer treatment missed its main goal, closing off an opportunity for an expanded approval.

By Ned Pagliarulo • Aug. 15, 2022

Messaging the right HCP at the right time via their electronic health record (EHR)

HCPs spend 3x the time in their EHR each day as they do online. How should that affect your approach to reaching HCPs?

Aug. 15, 2022

Pfizer’s new pneumococcal vaccine meets study goal in children

Pfizer, which competes with Merck in this market, plans to ask the FDA for an expanded approval of its 20-valent shot later this year.

By Delilah Alvarado • Aug. 12, 2022

Amgen’s low tax rates draw attention of top Democratic senator

Ron Wyden, D-Ore., is probing how Amgen paid an average effective tax rate of 12% over the past four years, well below the U.S. statutory rate of 21%.

By Ned Pagliarulo • Aug. 12, 2022

GSK, Pfizer, Sanofi shares drop amid Zantac litigation concerns

The companies could face liability related to their sales of the heartburn drug, which was withdrawn from the market in the U.S. and other countries after impurities related to a likely carcinogen were detected.

By Ned Pagliarulo • Updated Aug. 11, 2022

EQRx, in bid to compete, takes on AstraZeneca’s top seller in head-to-head trial

The study could be critical for a medicine EQRx plans to position as a competitor to Tagrisso. The drug is under review in the U.K., a first for EQRx.

By Kristin Jensen • Aug. 11, 2022

Novavax slashes revenue forecasts amid slow demand for COVID-19 vaccine

The biotech now expects about $2 billion in revenue in 2022, less than half its previous estimates, after sales fell sharply in the second quarter.

By Christopher Newman • Aug. 9, 2022

J&J’s head of R&D departs as pharma’s leadership turns over

Mathai Mammen is leaving to “pursue other opportunities,” J&J said in an abrupt announcement. William Hait, currently head of external innovation, will take Mammen’s place in the interim.

By Ned Pagliarulo • Aug. 9, 2022

Lilly criticizes Indiana abortion law, indicating it may look elsewhere to hire

After Indiana’s governor signed a near-total abortion ban into law, the drugmaker said it will rethink future hiring in the state.

By Delilah Alvarado • Aug. 8, 2022

Pfizer buys sickle cell drugmaker Global Blood for $5.4B

The acquisition gives Pfizer access to Oxbryta, an approved drug for the blood condition, as well as two experimental medicines.

By Delilah Alvarado , Ned Pagliarulo • Updated Aug. 8, 2022

How a small UK biotech ended up in Gilead’s hands

MiroBio, which was spun out of the University of Oxford three years ago, drew Gilead’s interest with its autoimmune disease research.

By Gwendolyn Wu • Aug. 5, 2022

Novo shares tumble after latest setbacks for closely watched obesity drug

The Danish drugmaker lost tens of billions in market value after revealing a key clinical study for Wegovy won't be stopped early and production issues are still being ironed out.

By Kristin Jensen • Aug. 4, 2022

With new data, Roche takes step toward more convenient cancer immunotherapy

The pharma claimed Phase 3 study success for a subcutaneous version of its drug Tecentriq, a strategy it and rivals Merck and Bristol Myers could use to extend the market life of their lucrative drugs.

By Ben Fidler • Aug. 2, 2022

The cost of purpose: Finding personal fulfillment in a pharmaceutical career

Wa’el Hashad, President and CEO of Avanir Pharmaceuticals, discusses purpose and fulfillment in a pharmaceutical career.

By Wa’el Hashad, President and CEO, Avanir Pharmaceuticals • Aug. 1, 2022

AbbVie cancer drug sales fall as AstraZeneca competitor gains ground

Imbruvica, long one of AbbVie’s top-selling medicines, has ceded market share in treating chronic lymphocytic leukemia to AstraZeneca’s Calquence.

By Ned Pagliarulo • July 29, 2022

Pfizer sales of COVID-19 vaccine, pill beat forecasts as company prepares for future waves

The company plans to ready a booster shot by the fall that targets the BA.4 and BA.5 strains that are currently most prevalent in the U.S. and other countries.

By Christopher Newman • Updated July 28, 2022

Novartis asks FDA to approve biosimilar for Biogen’s top-selling MS drug

Biogen will try to enforce patents protecting Tysabri, but an executive last week acknowledged that copycat drugs could launch when approved in the U.S.

By Jonathan Gardner • July 25, 2022

EU speeds approval of monkeypox vaccine as WHO declares public health emergency

Vaccine maker Bavarian Nordic said it is meeting demand for its shot with production capacity of 30 million doses a year.

By Christopher Newman • July 25, 2022

European regulator recommends Bavarian Nordic's vaccine for monkeypox

The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines.

By Christopher Newman • July 22, 2022

Roche CEO Schwan, who guided company as cancer drug powerhouse, to step down next year

The drugmaker’s current diagnostics chief Thomas Schinecker will take over as CEO in March, while Schwan will seek election as chair of Roche’s board.

By Jonathan Gardner • July 21, 2022

Roche digs deeper into gene therapy for the eye

The Swiss drugmaker, which already owns rights to a marketed gene therapy for inherited vision loss, will work with startup Avista Therapeutics to develop better delivery tools for the complex treatments. 

By Jonathan Gardner • July 20, 2022

Merck terminates Lynparza trial in colorectal cancer

The setback slows plans to broaden use of a drug that analysts expect to generate nearly $10 billion in annual sales later this decade.  

By Jonathan Gardner • July 19, 2022