Safety questions linger as Pfizer preps Duchenne gene therapy for final test

New data presented at the American Society of Gene & Cell Therapy's yearly meeting show promise, but also side effects that haven't been seen with a rival treatment from Sarepta.

By Ben Fidler • May 15, 2020

Ousted BARDA director: Hydroxychloroquine push distracted government scientists

Safety concerns led to a clash over how widely to distribute the malaria pill for use against COVID-19, Rick Bright testified to Congress Thursday. 

By Jonathan Gardner • May 14, 2020

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

J&J myeloma data heat up cell therapy battle

Bristol Myers' regulatory stumble opens the door for other companies developing CAR-T therapies for multiple myeloma to catch up. ASCO data released Wednesday show J&J could be closing the gap.

By Jonathan Gardner • May 13, 2020

Activist investor pushes Alexion to sell after Portola deal

Elliot Advisors cited Alexion's buyout of Portola, which triggered a sell-off last week, as reason to ask the biotech's board to solicit bids from larger pharmas.

By Jonathan Gardner • May 12, 2020

GenFit delivers latest NASH drug failure

The negative results for GenFit's elafibranor deal another another blow to the NASH field, which has seen only one drug make it through late-stage testing.

By Jacob Bell • May 11, 2020

MyoKardia pops as heart drug passes most important test

A late-stage study found patients with a condition similar to heart failure fared better when given MyoKardia's drug. The results sent company shares soaring.

By Jacob Bell • May 11, 2020

Lilly's Loxo buyout bears fruit as FDA clears cancer drug Retevmo

The pharma will launch Retevmo at a time when hospitals and academic centers are stretched thin by the COVID-19 pandemic. 

By Ned Pagliarulo • May 9, 2020

Novartis wins approval for niche lung cancer drug

Jumping ahead of competition, the Swiss pharma secured FDA clearance for Tabrecta, the first therapy targeted to certain mutations in a gene called MET.

By Jonathan Gardner • May 7, 2020

Novo's diabetes drug also appears to work in NASH

Results from a Phase 2 study showed three doses of Novo's semaglutide were better than placebo at resolving the liver disease without worsening fibrosis.

By Jacob Bell • May 6, 2020

Another delay for Bristol Myers cell therapy as FDA extends review

Bristol Myers now expects an approval decision on liso-cel by mid-November, some six weeks before a deadline set by the pharma in its buyout of Celgene.

By Kristin Jensen • May 6, 2020

Pfizer, BioNTech launch U.S. trial of coronavirus vaccine

Initial vaccine data are expected within weeks as biotech and pharma companies intensify their search for a way to prevent the spread of COVID-19.

By Jonathan Gardner • May 5, 2020

Using AI to align field engagements with strategy in medical affairs

Advanced AI technology can help pharmaceutical companies optimize the medical engagement process. 

May 5, 2020

A coronavirus vaccine may arrive next year. 'Herd immunity' will take longer.

Experimental vaccines for COVID-19 are moving at an unprecedented pace. But that could mean researchers won't definitively know whether they're safe and effective when they do arrive.

By Jonathan Gardner • May 4, 2020

Roche gets emergency OK for coronavirus antibody test as FDA tightens oversight

The Swiss pharma said its product may be less likely to deliver false positives than some earlier-to-market serology tests, a concern regulators attempted to address with a key policy update Monday.

By Nick Paul Taylor • Updated May 4, 2020

J&J contracts with Catalent to boost coronavirus vaccine production

The partnership is the second J&J has inked in recent weeks as it prepares sufficient capacity to supply 1 billion doses of its experimental vaccine.

By Kristin Jensen • April 30, 2020

AstraZeneca, racing past rivals, throws its weight behind Oxford's COVID-19 vaccine

The British drugmaker will take over development of an experimental vaccine that could produce its first clinical results next month.

By Ben Fidler • April 30, 2020

Pfizer resumes trial recruitment suspended by coronavirus

After pausing enrollment into many studies in March, Pfizer is beginning to resume clinical activities at sites that are currently operational.

By Jonathan Gardner • April 28, 2020

Merck starts to feel COVID-19's effects

The pharma giant lowered its 2020 revenue expectations by $2.5 billion as its vaccines, cancer drugs and animal health business face coronavirus-related pressures.

By Jacob Bell • April 28, 2020

Pharmas boosted by drug stockpiling, but warn of COVID-19 impact

Patients and wholesalers stocked up on medicines early in 2020, lifting first-quarter sales for many pharmas. But that boost is likely fleeting, disguising the substantial effects the pandemic is having on their businesses.

By Ned Pagliarulo • April 28, 2020

Repurposed arthritis drug disappoints in closely watched COVID-19 trial

A study of Regeneron and Sanofi's Kevzara will continue, but only for patients in the most critical condition after an early look suggested less-severe patients did worse than those taking placebo.

By Jonathan Gardner • April 27, 2020

Another step for PARPs as AstraZeneca, Merck drug extends lives in prostate cancer

Lynparza is now the first PARP inhibitor to help prostate cancer patients live longer versus hormone therapy, giving it an edge over rival Rubraca.

By Ben Fidler • April 24, 2020

Pharma's new mission: Bridging the care gap

While public health officials focus on fighting the virus itself, the pharmaceutical industry must look more broadly to continue realizing its purpose of discovering and delivering treatments to a world in need.

By Howard Deutsch, Pratap Khedkar, Peter Manoogian and Ganesh Vedarajan • April 21, 2020

Positive data keep Bristol Myers and Exelixis in the kidney cancer race

A combination of Opdivo with Exelixis' Cabometyx, if cleared for use, would compete against an approved pairing of Merck's Keytruda and Pfizer's Inlyta.

By Jonathan Gardner • April 20, 2020

Novartis, launching COVID-19 trial, seeks to prove hydroxychloroquine's worth

The Swiss pharma, one of hydroxychloroquine's many generic manufacturers, will soon start a randomized, placebo-controlled study of the malaria pill.

By Ned Pagliarulo • April 20, 2020

NIH spearheads broad partnership with drugmakers, regulators to speed COVID-19 therapies

The initiative reflects the urgency for drugmakers to work together, rather than independently, to advance promising treatments for the novel coronavirus.

By Ben Fidler • April 17, 2020