Recon: AstraZeneca buys Caelum, maker of rare disease drugs; FDA Considering Moderna Half-Dose Booster

Welcome to Regulatory Reconnaissance, your daily briefing on regulatory news and intelligence.

Focus: United States

• FDA misses GOP deadline on recall issues (Politico)
• FDA looks into authorization of half-dose Moderna booster (Bloomberg) (Reuters)
• FDA asks drugmakers to redo studies conducted by two contract research companies due to data integrity (STAT) issues (Endpoints)
• Side effects from a third dose of the vaccine are similar to those from the second, according to a CDC report. (NY Times)
• Pfizer’s Covid-19 vaccine for children may not be cleared by the FDA until November (WSJ)
• FDA approves AbbVie’s migraine prevention drug (Reuters)
• Editas CRISPR treatment improved vision for one patient, but not for others, according to early data (STAT)
• As lawsuits escalated, Purdue had conversations with a controversial drug addiction policy group (STAT)
• Drug distributors strike first opioid deal with Native American tribe for $ 75 million (Reuters)

Focus: international

• EMA implements new measures to minimize animal testing during drug development (EMA)
• COVID-19 pandemic has hurt UK cancer drug trials, industry body says (Reuters)
• India aims to produce Covid-19 mRNA vaccine this year (WSJ)
• AstraZeneca buys rare disease drug maker Caelum in potential $ 500 million deal (Reuters)
• I-Mab weighing partnership, sale of stake to pharmaceutical giants (Bloomberg)
• WHO workers sexually assaulted women during Ebola mission in Congo, survey says (NYTimes)

Coronavirus pandemic

• In COVID Fight, Nonprofits Ask White House for IP Waivers (Law360)
• Government response to Covid-19 will continue in shutdown, but health agencies will face significant staff shortages (STAT)
• Collapse in private vaccine sales in India hits Russian Sputnik V hard (Reuters)
• Slovenia temporarily suspends Janssen COVID-19 vaccine from J&J (Reuters)
• Pfizer asks Brazil to authorize booster dose of its COVID-19 vaccine (Reuters)
• Switzerland buys 150,000 doses of J&J COVID-19 vaccine (Reuters)

Pharma & Biotech

• More problems for Biocon insulin plant in Malaysia as FDA reports six sightings of Form 483 (Fierce)
• In order to attract more innovation in R&D, Europe seeks to rewrite its pharmaceutical legislation (Endpoints)
• Amicus Creates Gene Therapy Unit Under PSPC Agreement As It Shifts Efforts To Pompe Disease Control Program (Endpoints)
• Pfizer’s next-generation Prevnar 20 can be given with influenza vaccine, study finds (Fierce)
• The Alzheimer’s disease drug targets people with mild cognitive impairment. What does it mean? (KHN)
• US FDA aims to speed up communications on cell and gene therapy issues with question-and-answer advice (pink sheet)
• Drugging RNA was once considered impossible. Now Big Pharma Can’t Get Enough (Endpoints)

Medtech

• Medical device company pleads guilty to selling falsified devices, waives over $ 800,000 in non-FDA (DOJ) approved devices
• FDA clears Caretaker Medical (Fierce) wireless blood pressure monitoring finger sensor
• FDA medical device regulations, safety controls challenged by ethics journal AMA (MedtechDive)
• US FDA Shuren promises MDUFA update “relatively soon” (MedtechInsight)
• Newly Acquired Radial Arterial Catheters from Medtronic Go Global with European Approval (Fierce)
• Abbott braces for potential VALID diagnostics law while asking for more clarity (MedtechInsight)
• EU Medtech urgently needs more transparency on the capacity situation of EU Notified Bodies (MedtechInsight)
• What’s next for RADx? NIH writes to-do list for its $ 1.5 billion diagnostics competition, via COVID and beyond (Fierce)
• Bayer strengthens ties with Huma, collaborates on AI to classify types of lung cancer (Fierce)

Government, Regulation and Legal

• Endo Pledges $ 7.5 Million Agreement With La. AG Over Opioid Claims (Law360)
• Drug Cos. says DA’s objections to opioid regulation are immature (Law 360
• Gilead and Bristol Myers face lawsuits from major pharmacies over generic HIV drug delays (Endpoints)
• J&J Wins Multiplainer Mo. Talc Case After High Court Fail (Law360)
• Three New York men sentenced to prison for elaborate program to sell illegally imported drugs (FDA)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you key regulatory, biopharmaceutical and medical news from around the world.

Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.