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Regulatory Focus™ > News Articles > 2020 > 1 > Recon: Startup EQRx Raises $200M in Effort to Bring Cheaper Drugs to Market; Incyte Buys Rights to M

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

Posted 13 January 2020 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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 $110M for Next Wave of Gene Therapy, IPO Plans (Xconomy)
  • Saving hearts with HDAC inhibition (Nature)
  • Lyme Disease Vaccine Could Be Ready In 4 to 5 Years (Forbes)
  • Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 (PH1) (Press)
  • Lynparza granted Priority Review in US (PharmaTimes) (Press)
  • ViiV submits fostemsavir MAA to EMA (PharmaTimes) (Press)
  • Imago Receives Fast Track Designation from U.S. FDA for Bomedemstat for Treatment of Essential Thrombocythemia (Press)
  • Tenax Therapeutics Provides Update on Phase 2 Pulmonary Hypertension Clinical Trial (Press)
  • Novus Therapeutics Provides Update on OP0201 (Press)
  • Zymeworks Announces Agreement with Pfizer and Initiation of a New Phase 2 Trial Evaluating ZW25 in Combination with Ibrance® (palbociclib) (Press)
  • Neuropore Completes Phase 1 Clinical Trial in Healthy Volunteers with NPT520-34, a Therapeutic Candidate Aimed at Treating Parkinson’s Disease and Amyotrophic Lateral Sclerosis (Press)
  • Tyvyt (Sintilimab Injection) Combined with ALIMTA (Pemetrexed) and Platinum Met Predefined Primary Endpoint in Phase 3 ORIENT-11 Study as First-Line Therapy in Nonsquamous NSCLC (Press)
  • Aruvant gains Rare Pediatric status for sickle cell disease candidate ARU-1801 (PharmaLetter-$)
Medical Devices
  • 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)
US: Assorted & Government
  • 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-$)
Upcoming Meetings & Events Europe
  • EU Says Nitrosamine Risk Info Also Needed For New Drug Filings (Pink Sheet-$)
  • 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)
Asia
  • Pakistan registers cases against 200 pharmaceutical companies (Pharmafile)
  • Eisai debuts Halaven in China (PharmaLetter)
India
  • 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)
Australia
  • Access to medicinal cannabis products (TGA)
Other International
  • Improving Biosecurity With First International Standard For Biorisk Management (ISO)
General Health & Other Interesting Articles
  • 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)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
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A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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