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

• 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)

• 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)

• 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)

• 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)

• 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)