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Regulatory Focus™ > News Articles > 2020 > 9 > Recon: Catalyst loses orphan approval suit against FDA; California adopts law to pursue its own gene

Recon: Catalyst loses orphan approval suit against FDA; California adopts law to pursue its own generics

Posted 29 September 2020 | By Michael Mezher 

Recon: Catalyst loses orphan approval suit against FDA; California adopts law to pursue its own generics

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Top FDA vaccine official says vaccine guidance may never be released (Politico)
  • Catalyst loses lawsuit accusing the FDA of unfairly approving a rival rare disease drug (STAT)
  • Trump admin begins shipping rapid coronavirus tests to states (Politico) (Reuters)
  • Big Pharma Backs Joe Biden, But People Don't Think He'll Fix Drug Pricing (Newsweek)
  • Drug industry CEOs will testify this week about some of pharma’s most controversial medicines (STAT)
  • COVID-19 Vaccines: HHS Advisory Committee Urges ‘Great Caution’ On Use Of EUA (Pink Sheet)
  • An FDA safety program is failing to stem the opioid crisis, manufacturers mostly to blame (STAT)
  • With a new law, California becomes the first state to pursue its own line of generics (STAT)
  • Ironwood to cut 100 jobs after digestive disease drug fails study (Reuters) (Endpoints)
  • Pfizer’s Xeljanz approved by the FDA for the treatment of children with arthritis (Pharmafile) (Press)
In Focus: International
  • WTO should play role in COVID-19 medicine access: candidate (Reuters)
  • Serum Institute to boost production of COVID-19 vaccine doses to 200 million (Reuters)
  • Novacyt buoyed by UK Covid-19 diagnostics contract (FT)
  • India initiates probe against alleged dumping of pharma raw material by Chinese firms (Economic Times)
  • Junshi declares PhIII success on cancer that won them 'breakthrough' status (Endpoints)
  • Global partnership to make available 120 million affordable, quality COVID-19 rapid tests for low- and middle-income countries (WHO)
Coronavirus Pandemic
  • Global coronavirus deaths rise above 'mind-numbing' million (Reuters)
  • Opinion: Increase transparency at the FDA: We need sunlight to fight the pandemic (STAT)
  • Hologic receives FDA emergency use for asymptomatic COVID-19 test (MedtechDive)
  • Pfizer to Supply $22 Million in Drugs to Covid Stockpile (Bloomberg)
  • Russia to supply 25 million COVID-19 vaccine doses to Nepal (Reuters)
  • Studies Begin to Untangle Obesity’s Role in Covid-19 (NYTimes)
  • COVID-19 guidance for reporting medical device shortages: Background (Health Canada)
  • Information for sponsors: Supplying medicines during a shortage under section 19A (TGA)
Pharma & Biotech
  • Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA) (FDA)
  • Biogen's Aducanumab Advisory Committee Will Test US FDA's 'Substantial Evidence' Flexibility (Pink Sheet)
  • Slammed by FDA rejection, Aquestive vows to refile by end of year (Endpoints)
  • Black Diamond brings in ex-GSK CEO Bob Ingram to chart new path in precision oncology (Endpoints)
  • Eyeing their first approval, BridgeBio sends their first drug to the FDA and lands a speedy review (Endpoints)
  • Myovant shows disappointing prostate cancer data on the way to the FDA, stock sinks (Endpoints)
  • Belén Garijo rises to the top at Merck KGaA amid exec board makeover (Endpoints)
  • News briefing: PhIII Alzheimer's play draws another $33M+; Arranta unveils $100M+ microbiome manufacturing site (Endpoints)
  • MPM joins the historic SPAC boom as its blank check company files for an IPO (Endpoints)
  • Armed with a PhI cancer drug from Bayer, an Acerta founder breaks cover and writes himself a $60M blank check deal (Endpoints)
  • Approval Now in Hand, CureApp Looks at Collaborations with Drug Makers to Push Therapeutic Apps (PharmaJapan)
  • 'Sakigake' Treatment Gives Enhertu Rapid Japan OK For Gastric Cancer (Pink Sheet)
  • LabCorp aims to take Genfit's NASH liver diagnostic blood test into primary care (Fierce)
  • Abbott gets CE mark for latest CGM with Dexcom still in the wings (MedtechDive)
  • South Korea’s MFDS publishes draft regulatory revision and new guidance documents (Emergo)
Government, Regulatory & Legal
  • U.S. senators aim to stop sale of drugs online by going after tech's legal immunity (Reuters)
  • Failure-to-Report claims:  An Up-Hill Battle (Drug & Device Law)
  • Notification of amendments to the Poisons Standard in relation to New Chemical Entities (NCEs) and Salbutamol (TGA)
  • Fed. Circ. Revives Jury Ax Of Biogen MS Drug Patent (Law360)
  • Teva Fails To Get $110M Drug Contract Suit Tossed (Law360)
  • Hoffmann-La Roche Can't Shake $1.4B Tamiflu FCA Suit (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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