Recon: FDA to review first OTC birth control pill; EU recommends second COVID booster for over-60s

ReconRecon
| 11 July 2022 | By Joanne S. Eglovitch 

In Focus: US
  • Drugmaker seeks FDA approval of over-the-counter birth control pill (STAT) (Reuters) (Washington Post)
  • FDA grants full approval to Pfizer COVID vaccine for ages 12-15 (Reuters)
  • Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half (The Pink Sheet)
  • In wake of unexpected patient deaths, MacroGenics closes down PhII cancer trial (Endpoints)
  • Drug Pricing Plan Faces Industry Gripes as Senate Reconvenes (Bloomberg)
  • US orders 3.2M doses of Novavax COVID vaccine (Reuters)
  • Republicans Seek to Slow Collins-Shaheen Insulin Price-Capping Bill (FDAnews)
  • House Appropriators Call For CMS To Pay More For Domestic Generic Drugs And Biosimilars (The Pink Sheet)
  • Dobbs Isn’t Clear on State, Federal Abortion Authorities, Law Professors  Say (Inside Health Policy)
  • Florida Gov. DeSantis hints at suing FDA over stalled Canadian drug import plan (Endpoints)
  • Abbott says it has reopened Michigan baby formula plant (Reuters)
In Focus: International
  • EU backs second COVID booster for over-60s, before variant-adapted vaccines are ready (Reuters) (Bloomberg)
  • EMA Hails Success Of COVID-19 Multi-Regulator Collaboration (The Pink Sheet)
  • English Funding Rejections Reversed For Brukinsa, Adtralza, Cibinqo & Rinvoq (The Pink Sheet)
  • South Africa's Afrigen partners with U.S. on mRNA vaccine research (Reuters)
  • Swiss Agency Clarifies Its Expectations On Using RWE In Filings (The Pink Sheet)
  • Gay men, some trans people and sex workers should be vaccinated against monkeypox, French health body says (Reuters)
  • Hit by COVID, EU population shrinks for second year running, Eurostat says (Reuters)
  • Kenya, World Health Organization launch emergency hub (Reuters)
Pharma & Biotech
  • Another Indian drug manufacturer hit with a Form 483 over recent observations (Endpoints)
  • Two years after scrapping three hemophilia trials, Novo Nordisk plots route to FDA with new PhIII data (Endpoints)
  • Sanofi preps hemophilia duo for patients seeking as ‘normal a life as possible’ (Fierce)
  • German chemicals company to expand its reach into mRNA ingredient production (Endpoints)
  • Emergent inks deal to manufacture and sell Ridgeback’s Ebola drug in the US (Fierce)
  • Provention snags $60M in private placement as future of diabetes therapy hangs in the balance (Fierce)
  • Sobi Returns To Deal-Making With ADC Lymphoma Licensing Pact (Scrip)
  • Schrodinger eyes ‘hundreds’ of programs overs a decade amid clinical-stage evolution (Fierce)
  • Athersys loses $100M funding deal as C-suite exits allow backer to turn tail (Fierce)
  • Abbvie dumps Alector’s Alzheimer’s immunotherapy after phase 1 review (Fierce)
  • BeiGene Latest Chinese Biotech To Double Down On mRNA For Cancer (Scrip)
Medtech
  • Ex-Mazor executive charged by SEC with insider trading over Medtronic’s $1.6B buyout (MedTech Dive)
  • European Commission targets spring of 2024 for fully functional Eudamed database (MedTech Dive)
  • FDA denies Lumos Diagnostics bid for rapid test to differentiate between bacterial, viral infections (Fierce)
  • Survey: Semiconductor Shortage A Change Maker At Medtech Companies (MedTech Insight)
  • FDA Releases Plan For Enhancing eMDR Adverse Event Reporting System (MedTech Insight)
  • Sinopharm considering $1B buy for Shanghai-based DNA maker BBI Life Sciences: report (Fierce) (Bloomberg)
  • How Stormy UK Politics Could Intrude On Medtech Regulatory Readiness (MedTech Insight)
  • Hologic, Thermo Fisher launch molecular tests in EU for multiple respiratory viruses at once (Fierce)
  • CMS Proposes National Payments For Long-Term Continuous Electrocardiogram Monitoring (MedTech Insight)
  • Scientists design a cheap device that can detect ear problems with the help of a smartphone (STAT)
  • Korean diagnostics biotech goes transpacific, agreeing to shell out $1.5B to take Meridian private (Endpoints)
Government, Regulatory & Legal
  • BMS Settles Patent Dispute With Alembic Over Blockbuster Revlimid (FDAnews)
  • Former Theranos exec Ramesh Balwani convicted of fraud (STAT)
  • Teva's parent should be restored to New York opioid case, state attorney general says (Reuters) (Bloomberg)
  • Covid Testing Case Warns Employers on Genetic Bias Law Liability (Bloomberg)
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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