Recon: Startup EQRx Raises $200M in Effort to Bring Cheaper Drugs to Market; Incyte Buys Rights to MorphoSys CAR-T Rival

• JPM health conference kicks off (Politico)
• High Drug Prices? Pharma Startup Thinks It Has the Right Medicine (WSJ) (Axios) (STAT) (Endpoints) (Financial Times) (Fierce)
• FDA and NIH let clinical trial sponsors keep results secret and break the law (ScienceMag)
• Biogen to buy early-stage potential Alzheimer's, Parkinson's treatment from Pfizer (Reuters) (Endpoints)
• What roulette and basketball can teach Biogen about aducanumab (STAT)
• Maryland’s new prescription drug board meets for first time (WTOP)
• Inside Google’s Quest for Millions of Medical Records (WSJ)
• Veru's experimental drug reduces hot flashes in men in mid-stage study (Reuters)
• High cost of multiple sclerosis medicines is forcing many patients to take ‘drastic actions’ (STAT)
• Supreme Court will review an Arkansas law governing pharmacy benefit managers (STAT)
• Opinion: The FDA Is in Trouble. Here’s How to Fix It. (NYTimes)

• AstraZeneca to discontinue Epanova trial, expects $100 million writedown (Reuters)
• Acasti's krill oil-derived drug fails late-stage study, shares tumble (Reuters) (Endpoints)
• Switzerland's Obseva eyes China re-start for fertility drug that failed trial (Reuters)
• Incyte bets $900M on MorphoSys' CAR-T rival tafasitamab (Endpoints) (BioPharmaDive) (Evaluate)
• Bluebird bio launches beta thalassaemia gene therapy Zynteglo in Germany (PMLive)
• NHS Scotland recommends Janssen's Zytiga combo for newly diagnosed prostate cancer (Pharmafile)
• Welcome to 2020 – year of the proof of the MDR pudding (MedicalDevicesLegal)

• Biopharma ends decade with near-record investment — but is it going to the right places? (Endpoints)
• Biopharma dealmaking in 2019 (Nature)
• With $1.4 trillion on tap, healthcare will be deal city in 2020—and Big Pharma won't drive it all (Fierce) (BioPharmaDive)
• At 16, She’s a Pioneer in the Fight to Cure Sickle Cell Disease (NYTimes)
• The Partnership for DSCSA Governance Is Up and Running (RxTrace)
• Agios CEO forecasts ‘line of sight’ to more approved drugs and profits (STAT)
• PPD sets out $1B IPO plans as it launches new China labs (Fierce)
• Axsome picks up Pfizer's phase 3 fibromyalgia castoff (Fierce)
• Another opioid pain drug, really? FDA staff sound sour on Nektar analgesic (Endpoints)
• Chiesi Group and Apotex Inc. finalize agreement for acquisition of Ferriprox (Press)
• Adaptimmune Appoints Elliot Norry as Chief Medical Officer and Makes Changes to R&D Leadership (Press)
• Driving CARs to last (Nature)
• Woodcock: The US FDA Sets The Stage For Global Quality Dossiers (Pink Sheet-$)
• J&J plans to recruit a new generation of 'bilingual' scientists for a research facility blueprinted for the booming Bay Area (Endpoints)
• Shooting for $100M IPO, Schrödinger takes the wraps off its five internal drugs and discloses deal details (Endpoints)
• RA Capital, Canaan help infuse $50M into Alta-incubated biotech battling acquired resistance to TKIs (Endpoints)
• Charles River pens Takeda early-stage drugs deal (Fierce)
• Eli Lilly ditches NextCure pact (Fierce)
• Allogene, SpringWorks to Test Drug Combo in Multiple Myeloma Trial (Xconomy)
• Roche Pays $40M to Use Amunix Pharma’s Half-Life Extension Tech (Xconomy)
• Generation Bio Pockets $110M for Next Wave of Gene Therapy, IPO Plans (Xconomy)
• Saving hearts with HDAC inhibition (Nature)
• Lyme Disease Vaccine Could Be Ready In 4 to 5 Years (Forbes)
• Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles (FDA)

• Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 (PH1) (Press)
• Lynparza granted Priority Review in US (PharmaTimes) (Press)
• ViiV submits fostemsavir MAA to EMA (PharmaTimes) (Press)
• Imago Receives Fast Track Designation from U.S. FDA for Bomedemstat for Treatment of Essential Thrombocythemia (Press)
• Tenax Therapeutics Provides Update on Phase 2 Pulmonary Hypertension Clinical Trial (Press)
• Novus Therapeutics Provides Update on OP0201 (Press)
• Zymeworks Announces Agreement with Pfizer and Initiation of a New Phase 2 Trial Evaluating ZW25 in Combination with Ibrance® (palbociclib) (Press)
• Neuropore Completes Phase 1 Clinical Trial in Healthy Volunteers with NPT520-34, a Therapeutic Candidate Aimed at Treating Parkinson’s Disease and Amyotrophic Lateral Sclerosis (Press)
• Tyvyt (Sintilimab Injection) Combined with ALIMTA (Pemetrexed) and Platinum Met Predefined Primary Endpoint in Phase 3 ORIENT-11 Study as First-Line Therapy in Nonsquamous NSCLC (Press)
• Aruvant gains Rare Pediatric status for sickle cell disease candidate ARU-1801 (PharmaLetter-$)

• Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound (MedtechDive)
• US to probe Fitbit, Garmin, other wearable devices after Philips complains (Reuters)
• Baxter, Dexcom, Hologic preview earnings as JPM kicks off (MedtechDive)
• FDA OKs Abbott clinical trial of MitraClip in moderate risk patients (MedtechDive)
• Medtronic wins CE Mark for next-gen InterStim products (MassDevice)
• CareDx Receives CE Mark for AlloSeq cfDNA Kit (GenomeWeb)
• Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator (FDA)
• Geneoscopy’s Preventive Screening Test for Colorectal Cancer and Precancerous Adenomas Earns FDA Breakthrough Device Designation (Press)
• Paragonix Technologies, Inc. Announces FDA Clearance and U.S. Launch of the Paragonix SherpaPak™ Pancreas Transport System (PTS) (Press)

• Trump Administration Says Obamacare Lawsuit Can Wait Until After the Election (NYTimes)
• Government experts urge new talc testing standards amid asbestos worries (Reuters)
• Pharmaceutical Executives Face Prison Time In Case Linked To Opioid Crisis (NPR)
• Merck, Lilly and Amgen square off in appeals court over drug pricing in TV ads (Fierce)
• Federal Circuit Affirms Biosimilar-Related IPR Appeals; Bevacizumab Injunction Appeal Progresses (BigMoleculeWatch)
• Okla. AG, Endo Reach $8.75M Deal Over Opioids (Law360-$)
• Coalition Files Citizen Petition to Stop 'Unlawful' FDA Actions Against PGx Testing (GenomeWeb)
• FDA Is Its People (Alliance for a Stronger FDA)
• Cert-ainly Interesting Times for the FTC at the Supreme Court (FDA Law Blog)
• Spoliation & Third Party Subpoenas (Drug & Device Law)
• Becon Medical, Ltd. v. Bartlett (E.D. Pa. 2019) (Patent Docs)
• Ex-Genentech staffer cuts plea deal in 'brazen' oncology trade secrets case (Fierce)
• What The Budget Bill Has In Store For Medical Cos. (Law360-$)
• Judge Orders New Trial In Cook Medical Vein Filter Bellwether (Law360-$)
• How States Are Responding To The Insulin Price Crisis (Law360-$)
• High Court Wades Into ERISA Drug-Pricing Battle (Law360-$)
• Zimmer Wants Pa. Defective Hip Implant Case Tossed Again (Law360-$)

• FDA Advisory Committee Calendar
• Identification of Concepts and Terminology for Multi-Component Biomarkers Workshop – 23 March 2020

• EU Says Nitrosamine Risk Info Also Needed For New Drug Filings (Pink Sheet-$)
• Early access to medicines scheme (EAMS) scientific opinion: Isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma. (MHRA)
• Opinion: The Tories must learn from the Orkambi victory and keep drug-pricing off the table (The Guardian)

• Pakistan registers cases against 200 pharmaceutical companies (Pharmafile)
• Eisai debuts Halaven in China (PharmaLetter)

• Granules India says 'voluntarily' recalling ranitidine tabs (Economic Times)
• After price cap, local stent makers capture 60% of market (Economic Times)
• USFDA classifies inspection of Lupin's Tarapur facility as 'Official Action Indicated' (Economic Times)
• Alembic gets USFDA nod for Vilazodone Hydrochloride tablets used to treat depression (Economic Times)
• Maharashtra FDA faces massive staff crunch with barely 100 DIs to enforce compliance (Pharmabiz)
• Indian Pharma Market registers 8.8% growth in December 2019; slips from 32 month high of 14.5% in November (Pharmabiz)
• Sub-committee finalises draft guidelines on post-approval changes in drugs (Pharmabiz)

• Access to medicinal cannabis products (TGA)

• Improving Biosecurity With First International Standard For Biorisk Management (ISO)

• Facebook’s new tool promotes preventive health. But the company can’t tell if it’s working (STAT)
• Apple came to the world’s biggest tech conference for the first time in 28 years. It barely talked about health (STAT)