Joseph Keenan
FiercePharma
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Past articles by Joseph:
Catalent inks deal to manufacture Sarepta's DMD gene therapy
CDMO giant Catalent is in a deal with Sarepta Therapeutics to manufacture what could become the first gene therapy for Duchenne muscular dystrophy (DMD). → Read More
Moderna to name Montreal for new biomanufacturing facility: report
Moderna is expected to announce Friday that it has chosen the Montreal area for a new biomanufacturing production facility that will include a research center. | Moderna is expected to announce Friday that it has chosen the Montreal area for a new biomanufacturing production facility that will include a research center. → Read More
Merck taps Thermo Fisher to manufacture COVID pill in Canada for global rollout push
Merck & Co. signed a deal under which molnupiravir production will be conducted at Thermo Fisher Scientific’s Ontario, Canada, facility. If approved, the drug will be distributed to Canada, the U.K. and markets in the European Union, Asia Pacific and Latin America. The Ontario plant is one of only three production sites for the therapy in the world. → Read More
Merck will support Saudi Arabia effort to build biologics manufacturing operations
Merck has signed on to help SaudiVax of Saudi Arabia design and construct a multimodality biologics manufacturing facility as part of the country’s efforts to provide a more localized production infrastructure for the Middle East, Northern Africa region. → Read More
Merck marks a first with global health org to license its COVID-19 pill
Merck took a big step in combatting the global pandemic by inking a deal of firsts for the Medicines Patent Pool that allows the health organization to sub-license versions of molnupiravir and supply the COVID-19 oral medication to 105 low and middle-income countries. → Read More
Celltrion's manufacturing headache likely to delay Teva migraine drug until 2019: analysts
Teva officials said their migraine drug fremanezumab, a linchpin of their growth plans, might not be delayed by "limited" problems at the Celltrion plant where its active ingredient would be made. But analysts say those problems likely aren't as limited as Teva might have hoped. → Read More
Amid consternation in Israel, Teva shuts down Netanyahu’s request to keep Jerusalem plant open
Thanks for the advice, but no thanks. That's what Teva told Israeli officials Tuesday after Prime Minister Benjamin Netanyahu encouraged the debt-laden drugmaker to keep open its manufacturing facility in Jerusalem in the wake of last week’s announcement of stunning cuts worldwide. → Read More
AbbVie expands manufacturing footprint in Singapore with biologics unit
AbbVie has kicked off another phase of its Singapore manufacturing expansion by opening a new biologics unit that complements existing small molecule API production at the plant. → Read More
FDA concerned of possible drug shortages in wake of devastation in Puerto Rico
The FDA said it is concerned that disruption of drug manufacturing in Puerto Rico in the wake of devastation left by Hurricane Maria could lead to critical shortages of some drugs. → Read More
Hurricane Maria shutters much of Puerto Rico's pharma manufacturing
As Puerto Rico struggles to get its footing in the wake of the devastation left by Hurricane Maria last week, the pharmaceutical manufacturing industry on the island is effectively shut down as companies assess damage to plants and the condition of their employees. → Read More
Seqirus first to reach large-scale manufacture of cell-based influenza vaccines
Seqirus said it has achieved an industry first by producing a cell-based influenza vaccine on a commercial scale using a virus that has been grown in cells versus the traditional method of using chicken eggs. → Read More
Takeda wraps up construction of new $111M solid dosage plant near Berlin
Japanese pharmaceutical giant Takeda said it has completed construction of its new $111 million manufacturing plant on the outskirts of Berlin in Oranienburg, Germany. → Read More
Prescription-drug supply shortages fuel price hikes, new research shows
According to research published by the New England Journal of Medicine and reported by the Wall Street Journal, shortages of prescription drug supplies in the U.S. in recent years resulted in price increases for some drugs. → Read More
Teva begins cuts at NY plant it expects to shutter by early next year
Israel-based Teva Pharmaceuticals has begun letting staff go at its Pomona site in Haverstraw, NY, that the company expects to close by February. That facility produces niacin, which is used to treat cholesterol and triglyceride levels. → Read More
Teva issues another recall of antibiotics--this time from a Canadian plant
For the second time this year, Teva has issued a recall of antibiotics produced at one of its facilities. This time it’s a plant in Canada. → Read More
FDA again slaps Indian API-maker Unimark Remedies with warning letter over records, pests
The FDA, which has been on a campaign to get Indian drugmakers to conform with its regulations, slapped Unimark Remedies with another warning letter in which it cited two of the Mumbai-based drugmaker’s plants for keeping poor records, failing to train employees properly, and unsanitary conditions. → Read More
FDA issues Noven another warning letter for factory that produces ADHD patches
The FDA recently issued another warning letter to Noven, a standalone operating subsidiary of Japan-based Hisamitsu Pharmaceuticals, for lapses at its Miami production facility. → Read More
Sagent recalls more of its antibiotics manufactured in India
Sagent Pharmaceuticals ($SGNT) is widening its recall of antibiotics manufactured by one of its India-based contractors after a customer complained that small, dark particulate matter were found in the solution after it was reconstituted. → Read More
FDA places Chinese, Indian generic drug makers on ‘Red List’ for not paying fees
The FDA has placed four Chinese and Indian generic drug facilities on the so-called “Red List” that bans them from shipping products to the U.S. for failing to pay required fees and not meeting identification requirements. → Read More
Federal court rules using a CMO doesn’t invalidate drug patents
A federal court has ruled that hiring contract manufacturing organizations (CMO) cannot be used as a cause for a drug patent owned by a pharma or biotech company to be invalidated under what is referred to as the “on sale” bar. → Read More