Pharma: Page
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FDA advisers push back on FibroGen anemia drug
Safety worries led to a near-unanimous vote against roxadustat in kidney disease patients, dimming the approval chances of what would be the first pill to boost red blood cells.
By Jonathan Gardner • July 16, 2021 -
Merck details an immunotherapy 'milestone' in early breast cancer
Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives.
By Ben Fidler • July 15, 2021 -
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Brian Tucker / BioPharma Dive/BioPharma Dive
TrendlineTop 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 -
Christopher Furlong via Getty Images
AstraZeneca deal for Alexion to close soon as UK regulator clears acquisition
The go-ahead from British regulators was the last hurdle standing in the way of the two companies wrapping up their $39 billion deal announced last year.
By Kristin Jensen • July 14, 2021 -
Courtesy of Eli Lilly
Lilly wagers up to $1B on a biotech's plan for a new type of insulin
Rival Novo Nordisk has jumped ahead in developing an injectable drug that responds to changes in blood sugar. An acquisition of Protomer Therapeutics could help Lilly close the gap.
By Jonathan Gardner • July 14, 2021 -
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FDA flags rare side effect in new warning on J&J's coronavirus vaccine
The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of an immune-driven condition known as Guillain-Barré.
By Jonathan Gardner • July 12, 2021 -
Permission granted by Biogen
Alzheimer's Association, insurers press Medicare for coverage rules on Aduhelm
Days after the FDA narrowed the target population for Biogen's drug, the patient advocacy group said it's urging Medicare to adopt a nationwide policy. Payers are seeking guidance, too.
By Jonathan Gardner • Updated July 12, 2021 -
Mark Makela via Getty Images
Healthcare mergers, 'pay for delay' deals get added scrutiny under Biden order
The executive order issued Friday calls on regulators to "enforce the antitrust laws vigorously" and to ban the controversial agreements that can slow the arrival of generic drugs.
By Samantha Liss • July 9, 2021 -
Warren Little via Getty Images
GSK returns to brain drugs with major biotech deal
The pharmaceutical giant best known for its work in cancer, HIV and respiratory illnesses is now paying at least $700 million to get its hands on two experimental drugs from Alector.
By Jacob Bell • July 2, 2021 -
Courtesy of Sanofi
Sanofi dives deeper into mRNA in search for next-generation vaccines
The French pharma plans to invest nearly $500 million annually on a new "center of excellence" meant to speed the development of mRNA vaccines, which have come of age during the pandemic.
By Jonathan Gardner • Updated June 29, 2021 -
Courtesy of Eli Lilly
Coronavirus variants deal another blow to Lilly's COVID-19 drug business
The U.S. government has stopped distributing the drugmaker's COVID-19 antibody combination nationwide, just two months after the FDA pulled its other antibody treatment from the market.
By Ben Fidler • June 28, 2021 -
Jose Luis Pelaez Inc/Blend Images
Sponsored by IQVIAReveal the "hidden clinical leaders" who drive HCP network adoption
Optimizing your insights into HCP/thought leader networks is critical for promoting new treatments.
June 28, 2021 -
With Alzheimer's drugs in focus, Bristol Myers rejoins the hunt
The pharmaceutical giant is spending $80 million for an exclusive license to an experimental drug developed by Prothena.
By Jacob Bell • June 24, 2021 -
Courtesy of Eli Lilly
Reversing course, Lilly to seek fast approval for experimental Alzheimer's drug
The drugmaker said it will file an application with the FDA later this year for accelerated approval of donanemab, a change of plans that comes weeks after the FDA's controversial clearance of Biogen's Aduhelm.
By Ned Pagliarulo • Updated June 24, 2021 -
Courtesy of GSK Flickr page
GSK outlines ambitious 10-year plan, but hits investors' near-term outlook
Under pressure from activist investors, the British drugmaker set lofty sales targets for a "new GSK" after a planned exit from consumer health. But shareholders will first face a dividend cut.
By Jonathan Gardner • June 23, 2021 -
Merck says Keytruda extends survival in cervical cancer study
Results from a Phase 3 study could help Merck secure a full approval for use of Keytruda in the tumor type, potentially extending the therapy's edge over rival therapies.
By Jonathan Gardner • June 22, 2021 -
Long-term Zolgensma data backs up gene therapy's use in youngest patients
With more and more states screening for SMA at birth, the study results are important for assessing Zolgensma's benefits when given very early on.
By Jonathan Gardner • June 21, 2021 -
Permission granted by Bristol-Myers Squibb
Bristol Myers partners with Eisai in $650M deal for targeted cancer antibody
The U.S. drugmaker is the latest to invest large sums of money in antibody-drug conjugates, following recent deals by Gilead, Merck and AstraZeneca.
By Jonathan Gardner • June 18, 2021 -
Anthem joins insurer-backed generics effort CivicaScript
The subsidiary of hospital-owned nonprofit CivicaRx plans to make six to 10 common generic drugs that don't have enough competition to drive down cost.
By Rebecca Pifer Parduhn • June 16, 2021 -
Chip Somodevilla via Getty Images
Former FDA chief Hahn joins venture firm that launched Moderna
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
By Jonathan Gardner • June 15, 2021 -
Permission granted by Emergent Biosolutions
Sponsored by Emergent BiosolutionsLyophilized products are on the rise: Here's what you need to know
To extend the shelf life and improve stability of biopharmaceuticals, a freeze-drying process—and a partner—can help.
By Kate Silver • June 14, 2021 -
Sarah Silbiger via Getty Images
As trials progress, FDA weighs COVID-19 vaccine authorizations for children
An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean vaccination of kids under 12 is unnecessary.
By Jonathan Gardner • June 11, 2021 -
Permission granted by Bristol-Myers Squibb
Bristol Myers says CAR-T therapy beat chemo, transplant in lymphoma study
The results could help support taking CAR-T therapy into earlier lines of cancer treatment, a long-held goal for the complex cellular drugs.
By Ned Pagliarulo • June 10, 2021 -
Brian Tucker/BioPharma Dive
Deep Dive'The lights are no longer green': Antitrust regulators reassess pharma deals
The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues to where they may look next.
By Jonathan Gardner • June 10, 2021 -
Erik S. Lesser via Getty Images
US bets $1.2B on Merck's last hope for a COVID-19 drug
Though most of Merck's COVID-19 efforts have come up short, its antiviral pill could still have a role, as signaled by the U.S. government's sizable financial commitment.
By Ben Fidler • June 9, 2021 -
Biogen Alzheimer's approval could open the door for similar drugs
Approval of Aduhelm sets a precedent that could enable some drugs, like Eli Lilly's drug donanemab, to advance quickly and cause other previously sidelined ones to get a second look.
By Jonathan Gardner • June 9, 2021
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