Recon: Gilead to buy Immunomedics for $ 21B; Trump signs international reference price order

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

In focus: USA

• Trump unveils plan to cut drug-related drug costs abroad (Politico) (NYTimes) (WSJ) (COUNTRY)
• Trump pushed for plasma therapy. Officials worry, is it further a yellowingless vaccine? (NYTimes)
• Gilead reaches deal to buy immunomedicine for $ 21 billion (WSJ) (FT) (Reuters) (COUNTRY)
• Merck to buy $ 1 billion stake in Seattle Genetics, co-development of cancer therapy (Reuters)
• Trump officials intervene in CDC reports on Covid-19 (Politico)
• US Employers Cut Out $ 6 Billion in Vain Drug Eyes (Bloomberg)
• The Kodak Agreement draws review from the observer to the agency involved in the planned loan (WSJ)
• Pfizer and BioNTech announce plan to extend Covid-19 vaccine trial (COUNTRY) (Reuters) (press)
• Arthritis drug Eli Lilly helped Covid-19 hospitalized patients recover faster (WSJ) (press)
• FDA rejects Mallinckrodt kidney drug on suspicion of risk benefits (Wild) (Final points)
• The vaccine maker received $ 1 billion from taxpayers. Now it is raising the prices of medicines (LA Times)

In Focus: International

• WHO chief urges rich nations to join vaccine scheme by Friday (Reuters)
• Oxford and AstraZeneca resume trial of coronavirus vaccine (FT) (Reuters)
• Regeneron antibody drug was added to the UK Recovery trial of COVID treatments (Reuters) (BBC)
• Coronavirus: MB to test for inhaled vaccines (BBC)
• Russia completes voluntary recruitment for COVID-19 vaccine trial: fund (Reuters)
• The United Arab Emirates announces emergency approval for the use of the COVID-19 vaccine (Reuters)
• Roche says two-thirds of Evrysdi patients had received rival treatments (Reuters)
• Novartis intends to expand Beovu use as security fears undermine launch (Reuters)
• Canadian Pascal Biosciences partners with SoRSE to test cannabis-based cancer therapy (Reuters)

Coronavirus pandemic

• Vaccine makers keep security details scientists calm and alert (NYTimes)
• Covid vaccine not enough for everyone until 2024, says the largest manufacturer (FT)
• Trump loyalists tried to influence CDC virus reports (NYTimes)
• Early research by 23andMe strengthens the link between blood types and Covid-19 (COUNTRY)
• Gilead CEO: We are exploring new ways to treat coronavirus with remdesivir out of hospital (CNBC)
• As trials of COVID-19 vaccines move at breakneck speed, recruiting black volunteers takes time (NPR)
• Valneva announces major COVID-19 vaccine partnership with UK government (PMLive)
• Coronavirus Update (COVID-19): Daily Summary September 11, 2020 (FDA)

Pharma & Biotech

• Neurocrine initiates Parkinson’s therapy after COVID-19-related disruptions are alleviated (Reuters)
• Cancer projects to diversify genetic research receive new grants (NYTimes)
• PIC / S Interprets Checklist for Audit of GMP Drug Inspectorates (Pink leaf)
• How much is a startup worth? For biotechnology companies, the answer is rarely public (COUNTRY)
• US FDA Oncology Applications: Real-time display and progress path show consistent appeal (Reuters)
• ICER criticizes the cost of 8 UC-targeted immune modulators, recommending some deep reductions (Final points)
• Gilead player CAR-T Kite bids farewell to search chief Peter Emtage while another senior executive hits the exit (Final points)
• Arie Belldegrun and David Chang godfather launch $ 110 million of a new cell therapy player. And he is also thinking a lot (Final points)
• Thanks to a $ 77.5 million Serie B, Escient moves to the clinic with its first sensory receptor candidate (Final points)
• Escape Bio raises $ 73 million as competition with Biogen and Denali with good heels heats up (Final points)
• The strongest unapproved application of stem cells accompanies the FDA Center for Advances in Cell Biology and Gene Therapy (IPQ)
• FDA Prescribes Dupixent® (Dupilumab) Progressive Therapy for Eosinophilic Esophagitis (press)
• Novartis reports positive topline results from the first phase III test of Beovu® versus aflibercept in patients with diabetic macular edema (DME) (press)
• Novartis data show that early treatment with Mayzent® (siponimod) delays the progression of disability and shows benefits in cognitive performance in patients with progressive multiple sclerosis (SPMS) (press)

Medtech

• Abbott, Illumina, other medtechs form guides that convey device risks to patients (MedtechDive)
• Fitbit will launch the first ECG app in the US, Europe next month (Wild)
• MHRA Lee will give Medtech Industry in the UK the Greatest Focus on Diagnosis (MedtechInsight)

Government, Regulatory & Legal

• The Patent Board gives a kick to the University of California over its claims for the CRISPR invention (COUNTRY) (science)
• A Pennsylvania lawmaker wants to link prescription drug prices to those paid by Canada (COUNTRY)

Regulator Recon is our daily intelligence information on the space of regulatory issues, bringing you the best regulatory news, biofarm and medtech from around the world.

The inclusion of a story in the Recon Regulation does not imply endorsement by the Focus Regulator or RAPS.