Recon: Catalent Shelling out $315M for Cell Therapy CDMO; Gilead, GSK Join Coronavirus Effort

• Catalent triggers a $315M-plus wager on the booming cell therapy market (Endpoints) (Fierce) (Press)
• Aimmune wins approval for peanut immunotherapy, charges $10k+ (Endpoints) (STAT) (FDA) (Press)
• Eli Lilly prices migraine therapy at $640 for pack of eight pills (Reuters)
• Accelerated FDA approval for Seqirus’ Audenz (Pharmaletter) (Press)
• New FDA chief plans for 'the most serious scenarios' of coronavirus outbreak (Politico)
• US declares coronavirus health emergency, bars foreign nationals who visited China (Reuters)
• Trump says US has 'shut down' coronavirus threat; China shuns US help (Reuters) (Politico)
• Employers shoulder plenty of drug costs, but haven’t lobbied much to lower them — until now (STAT)

• Brexit trade deal clash: UK and EU spar over rules (Reuters)
• Gilead working with China to test Ebola drug as new coronavirus treatment (Reuters)
• British drugmaker GSK to collaborate with CEPI in effort to develop coronavirus vaccine (Rueters)
• Big-caps join the coronavirus scramble (Evaluate)
• China says coronavirus death toll rises to 361, confirmed cases 17,205 (Reuters)
• European regulators could take a harder line on the review of an Agios blood cancer drug (STAT)
• Biotech Firm InnoCare Delays Hong Kong IPO Step on Virus Fears (Bloomberg)
• AbbVie's Rinvoq continues march with NICE nod in rheumatoid arthritis (Fierce) (PharmaTimes)
• Another HIV vaccine strategy fails in large-scale study (ScienceMag)
• EU flags are up in EMA’s new building in Amsterdam (EMA)
• WHO Executive Board appoints directors for Africa and Europe (WHO)

• The power of precedent: How a one-off decision by Janet Woodcock established an unintended fast pathway at the FDA — what will follow? (Endpoints)
• The Rise of Biosimilars: Success of the BPCIA? (Part II) (Harvard Bill of Health)
• Amgen, Pfizer biosimilar sales pressure top drugs (BioPharmaDive)
• Rosenberg study opens wider door to personalized TCR therapies for cancer (BioCentury)
• FDA Officials Suggest Ways To Smooth Path For Breakthrough Drug Approvals (Pink Sheet-$)
• Call Me, Maybe (LifeSciVC)
• FDA Updates and Press Announcements on NDMA in Metformin (FDA)
• Aerie Pharmaceuticals hires former Allergan, Alcon exec to help lead clinical, medical affairs (Fierce)
• Failed pivotal study? You can still have breakthrough therapy status — FDA signals to Resverlogix (Endpoints)
• How much does it cost to bootstrap a gene therapy startup? Not too much if you're Jim Wilson, per Passage Bio's $125M IPO filing (Endpoints)
• Revolution Medicines shoots for $150 million IPO; Novartis vet heads to Boston Pharma (Endpoints)
• Chan Zuckerberg Initiative to fund 30 patient groups, aiming to build a model for tackling rare diseases (STAT)
• Roche vet Sandra Horning jumps on biopharma board no. 3 — what’s that worth? (Endpoints)
• FDA’s Getting Its Priorities Straight: Revised ANDA Priority MAPP (FDA Law Blog)

• United Therapeutics' drug fails PhII/III cancer trial, marking their second straight stumble in post-Remodulin PAH (Endpoints) (Xconomy)
• FDA Accepts For Review Supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) (Press)
• TherapeuticsMD Announces Submission of New Drug Application Prior Approval Efficacy Supplement to the U.S. Food and Drug Administration for Lower Dose of BIJUVA® (Press)
• RegeneRx Partner Updates on Phase 3 Dry Eye Trial (Press)
• Insmed Announces Positive Top-Line Results from Phase 2 WILLOW Study of INS1007 in Patients with Non-Cystic Fibrosis Bronchiectasis (Press)
• Can-Fite Completes 50% Patient Enrollment in Phase III Rheumatoid Arthritis Study & Implements Interim Analysis (Press)
• Moleculin Announces Successful Completion of US Phase 1 AML Trial of Annamycin (Press)

• Amid coronavirus outbreak, FDA and industry seek roadmap for emergency diagnostics (MedtechDive)
• These medical device companies provide the most research payments (MassDevice)
• Boston Sci issues urgent field safety notice for Maestro cardiac ablation system (MassDevice)
• Translational Software to Submit PGx Software Platform for 510(k) Clearance (GenomeWeb)
• NeuMoDx T. Vaginalis, M. Genitalium Assay CE Marked (GenomeWeb)
• Its DOJ case settled, ResMed tops revenue expectations in Q2 (MedtechDive)

• FDA’s FY 21 Appropriation: What’s Happening When? (Alliance for a Stronger FDA)
• Life Sciences Court Report (Patent Docs)
• Biosimilar Appellate Update: Genentech v. Immunex, Genentech v. Amgen, Janssen v. Celltrion (Big Molecule Watch)
• Response/Rebuttal to Plaintiffs’ Albrecht Arguments (Drug & Device Law)

• FDA Advisory Committee Calendar
• Public Workshop: FDA/FTC Workshop on a Competitive Marketplace for Biosimilars – 9 March 2020

• Medtech in limbo as Brexit arrives (MedtechDive)
• EMA 2020 Budget Commentary (EMA)
• European Medicines Agency - Privacy statement for Selection and Recruitment (EMA)
• EU: PRIME Success For Givlaari At CHMP (Pink Sheet-$)
• Belgian Law Seeks To Tackle Drug Shortages (Pink Sheet-$)
• Brexit deal could negatively impact medical device development in UK, says report (EPR)
• Time to ‘turn the page,’ says Greek pharma trade group SFEE (Pharmaletter-$)
• What Happens To The FMD In the UK After Brexit Day? Seriously, Does Anyone Know? (RxTrace)
• Class 2 Medicines recall: Medreich PLC, Ranitidine 150mg Tablets, PL 21880/0091, Ranitidine 300mg Tablets, PL 21880/0092 (EL (20)A/05) (MHRA)
• EAMS Scientific Opinion: polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are not eligible for hematopoietic stem cell transplant (MHRA)

• Teva and Otsuka closer to Ajovy approval in Japan (Pharmaletter-$)
• Qilu’s biosimilar Ankada needs strong commercialization strategy in China, says analyst (Pharmaletter-$)
• Asia Deal Watch: China’s BravoVax, US-based GeoVax Team Up On Coronavirus Vaccine (Scrip-$)

• Cardiac stents account for 47.95% of total medical device associated SAEs reported so far (Pharmabiz)
• Proposals on medical device manufacturing will help grow domestic industry (Economic Times)
• Budget 2020: Govt to use proceeds from taxing medical devices for setting up hospitals in tier 2 and 3 cities (Economic Times)
• Cess on medical device imports may cast a shadow on US deal (Economic Times)
• Health Budget too meagre to have any impact: IMA (Economic Times)
• Budget 2020: Govt to launch campaign to eliminate TB by 2025, says FM Sitharaman (Economic Times)
• Why gene data will put India on the map (Economic Times)

• Wuhan Coronavirus Looks Increasingly Like a Pandemic, Experts Say (NYTimes)
• Coronavirus has put globalisation into reverse (Financial Times)
• China's Premier Li asks EU to facilitate urgent procurement of medical supplies (Reuters)
• China to exempt taxes for imports of products related to virus control (Reuters)
• China seeks to boost economy as first virus death reported outside its borders (Reuters)
• China facing global isolation as virus toll rises (Reuters)
• China says U.S. creating, spreading fear after virus outbreak (Reuters)
• 195 Quarantined in California After Fleeing Coronavirus Epicenter (NYTimes)
• Pentagon to provide housing support for 1,000 people who may need to be quarantined (Reuters)
• U.S. confirms 11th case of new coronavirus (Reuters)
• Cocktail of flu, HIV drugs appears to help fight coronavirus: Thai doctors (Reuters)
• U.S. disinfectant maker boosts output as China hospitals battle virus (Reuters)
• Gilead surges wildly as world scrambles to counter a likely coronavirus pandemic while GSK pitches in on vaccine R&D campaign (Endpoints)
• As China battles coronavirus, should other countries worry about their drug supply? (Fierce)
• Swedish health authority says woman is confirmed to have coronavirus (Reuters)
• First Case of 2019 Novel Coronavirus in the United States (NEJM)