Industry News
Pharmaceutical Industry News
Scholar Rock’s bid to win the…
Scholar Rock’s bid to win the first FDA approval for a muscle-targeted treatment for spinal muscular atrophy has been tripped up by inspection issues at a former Catalent production site in Indiana, now owned by
Catalent cut the ribbon on its new…
Catalent cut the ribbon on its new global corporate headquarters in Florida as the CDMO giant nears the anniversary of its sale to Novo Nordisk.
Kenvue, the Company Behind Tylenol, Tries to Navigate Its Latest Crisis
Kenvue, a two-year-old spinoff from Johnson & Johnson, is confronting a public-relations nightmare as President Trump and others suggest unproven links between the pain reliever and autism.
La empresa detrás de Tylenol intenta sortear su crisis más reciente
Kenvue, una empresa derivada de Johnson & Johnson, se enfrenta a una pesadilla de relaciones públicas ya que el presidente Trump y otros sugieren vínculos no probados entre el analgésico y el autismo.
These Patients Got the Cure. Then It Went Away.
Gene therapies for rare diseases are frequently developed then discarded by drug companies because they can’t afford to produce the treatment for more patients.
Along with promoting an autism…
Along with promoting an autism symptom treatment in GSK's Wellcovorin (leucovorin), the FDA issued a letter to physicians warning against Tylenol use during pregnancy as updates its safety label to include a potential link to
The FDA has issued a complete…
The FDA has issued a complete response letter to Lundbeck and Otsuka, scuppering their ambition to launch the atypical antipsychotic Rexulti—in combination with Viatris’ Zoloft—as a novel treatment for post-traumatic stress disorder.
Health officials are expected to…
Health officials are expected to link Tylenol use during early pregnancy to autism and propose a potential treatment in leucovorin, a med used to counter the toxicity of certain chemotherapies, according to the newspaper.
With a Sept. 29 deadline looming…
With a Sept. 29 deadline looming for pharmaceutical companies to adhere to President Donald Trump’s most favored nation drug pricing system in the U.S., Bristol Myers Squibb has revealed that it will offer schizophrenia drug
As Halloween approaches, Exact…
As Halloween approaches, Exact Sciences is warding off a particularly terrifying occurrence: skipping colorectal cancer screening.
Novo Nordisk’s Woes Are Slimming Denmark’s Economic Growth
Because of its size, the drugmaker has an outsize effect on the country. Now, as it sheds jobs, forecasts for Denmark’s growth are falling, too.
FDA OKs New Keytruda Shot for Cancer
The F.D.A. approved Merck’s injected version of its blockbuster infusion Keytruda. The company says it will be quicker and easier, but it stands to slow the adoption of cheaper competitors and increase costs by billions
America’s Vaccine Future Is at a Crossroads
“We should be thinking that we’re heading for more damaging changes.”
After a tumultuous journey filled…
After a tumultuous journey filled with delays and rejection, the FDA has approved Stealth BioTherapeutics’ treatment for the ultrarare disease Barth syndrome, marking the peptide as the first therapy for the condition.
As AI plays an increasingly…
As AI plays an increasingly important role in health and pharma marketing, leaders at agencies and organizations who spoke with Fierce Pharma Marketing pointed to a remarkably diverse number of ways the technology is having
In the second and final day of the…
In the second and final day of the CDC’s Advisory Committee on Immunization Practices September meeting, members of the panel scrapped one vote, reversed another and stopped just short of endorsing a third that had
The FDA has approved Merck &…
The FDA has approved Merck & Co.’s under-the-skin version of Keytruda, reducing treatment time burden for patients while granting the world’s best-selling drug potential blockbuster revenue protection.
Takeda employees from around the…
Takeda employees from around the world climbed Mount Fuji, a challenge that was meant not only to represent and celebrate the recent rollout of several of the company’s PDTs in Japan but also to raise
The CDC’s recommendation for…
The CDC's recommendation for Gilead's twice-yearly Yeztugo as an HIV PrEP option was hailed by HIV advocacy groups but stirred up pressure for CVS Health to include the drug on its formularies.
Europe’s Committee for Medicinal…
Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended several drugs for approval, including Novo Nordisk's once-weekly diabetes drug Kyinsu and Bayer's menopause treatment Lynkuet.