Recon: NICE Rejects J&J’s Spravato; Pfizer Aims for Phase III Gene Therapy Trials in 2020

• Biotech earnings preview: Unsettled investors hoping for strong 2020 outlooks (STAT)
• US Drugmakers Ship Therapies to China, Seeking to Treat Coronavirus (WSJ)
• Acceleron pulmonary hypertension drug succeeds in mid-stage trial (STAT) (Endpoints) (Reuters)  (Press)
• Incyte's skin disease drug meets main goal in late-stage study (Reuters) (Endpoints)
• Pfizer profit misses as breast cancer drug sales fall short of estimates (Reuters) (Press)
• Pfizer lays out gene therapy aspirations (BioPharmaDive)
• Gene therapies could add $45B to health care costs over next five years (BioWorld)
• Big drug purchasers predict price hikes driven by expensive new therapies (STAT)
• Advanced Therapies Are Reshaping Biopharma R&D: KPMG Report (Xconomy)

• China says death toll from coronavirus rises to 106, confirmed cases hits 4,515 (Reuters)
• WHO chief says confident in China's ability to contain virus, urges calm (Reuters) (WHO)
• TB vaccines can vary greatly, study finds. But does that mean some are less protective? (STAT)
• UK healthcare cost agency rejects J&J's nasal spray for depression (Reuters) (Endpoints) (PMLive)
• NICE rejections continue, hitting Novo’s Saxenda next (PharmaTimes)
• GSK licenses its tuberculosis vaccine to Gates MRI (PMLive)
• Guido Rasi - The Face Of The EMA For A Decade (Pink Sheet-$)

• Global Pharma & Life Sciences deals insights Year-end 2019 (PwC)
• Pfizer axes 6 early to late-stage cancer studies from the pipeline — with one other cut for sickle cell disease (Endpoints)
• ‘Small’ tactics to counter Big Pharma’s influence on medication overload (STAT)
• Allergan unveils new Botox plant ahead of $63B AbbVie merger (Fierce)
• Flagship's first venture of 2020 is out, and it's all about sperm (Endpoints)
• Quench Bio Springs From Atlas With $50M for a New Take on Inflammation (Xconomy            )
• Can we make the antibiotic market great again? (Endpoints)
• The new drug development -- collaborative and people-powered (BioCentury)
• Single dose of psychedelic drug eased cancer patients' anxiety, depression for years (NBC)
• Biogen Value-Based Contract Links Patient-Reported Outcomes To MS Drug Reimbursement (Pink Sheet-$)
• Ex-Novartis CEO Joe Jimenez is taking another crack at opening a new chapter in his career — and that includes a new board seat and a $250M startup (Endpoints)
• Krystal Biotech investing up to $90M on facility for its gene therapies (Fierce)

• First human trial of monoclonal antibody to prevent malaria opens (NIH)
• US FDA approves only triple-combination tablet with Jardiance® for adults with type 2 diabetes (Press)
• FDA gives new priority review for Sanofi and Regeneron's Dupixent (Reuters) (Press)
• Arrevus Receives FDA Qualified Infectious Disease Product (QIDP) Designation for the Treatment of Cystic Fibrosis Pulmonary Exacerbations (Press)
• Blueberry Therapeutics receives clearance from the FDA to proceed with the clinical investigation of BB2603 (Press)
• Intraoperative Molecular Imaging of Non-Small Cell Lung Cancer Improves Outcomes for 26 Percent of Patients in Multi-Institutional Phase 2 Clinical Trial (Press)
• Syros Announces First Patient Dosed in Phase 1 Clinical Trial of SY-5609, Its Highly Selective and Potent Oral CDK7 Inhibitor, in Patients with Select Solid Tumors (Press)
• Ikena Oncology Announces Dosing of First Patient in Phase 1 Study Evaluating IK-175 in Patients with Advanced Solid Tumors (Press)
• OncoImmune Announces Presentation of CD24Fc Phase IIa Data and Phase III Clinical Trial Design at the 2020 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (Press)

• Philips and ResMed may lose share in growing market for sleep tech: survey (MedtechDive)
• CMS widens NGS test coverage for inherited breast, ovarian cancers (MedtechDive)
• 3M posts wider-than-forecast losses in Q4 results (MassDevice)
• 3M lays off 20 employees at Acelity (MassDevice)
• Philips slides on 4Q bottom-line dip (MassDevice)
• King Systems recalls some video laryngoscope video adapters (MassDevice)
• Eko AFib and heart murmur algorithms win FDA clearance (MassDevice) (Press)
• Mauna Kea Technologies Receives FDA 510(k) Clearance of Cellvizio® with a Fluorescent Dye, Fluorescein, as Drug Device Combination (Press)

• Trump administration resolves fentanyl dispute but congressional support needed for broader crackdown (Reuters) (DOJ)
• The coronavirus gives Trump his biggest outbreak emergency yet — and experts are worried (STAT)
• It’s the insulin, stupid: How drug pricing’s simplest case study became a top issue for 2020 Democrats (STAT)
• Electronic Health Records Vendor to Pay $145 Million to Resolve Criminal and Civil Investigations (DOJ)
• Mike Bloomberg joins a growing chorus of Democratic presidential candidates threatening to go after drug patents (Endpoints)
• Harvard’s Chemistry Chair Charged on Alleged Undisclosed Ties to China (WSJ)
• Pharma Cos. Push 9th Circ. To Pause Calif. Pay-For-Delay Law (Law360-$)
• Insys Doc Who Lied About Ex-Colleagues Gets Nearly 5 Years (Law360-$)
• Stryker Can't Move Ex-Worker's Suit From Calif. (Law360-$)
• McKesson reaches $175 million deal with shareholders over lax oversight of opioid shipments (STAT)
• Is This the Final Blow for the Accutane Litigation? (Drug & Device Law)
• J&J CEO questioned over stock sale ahead of story on asbestos in Baby Powder (Reuters)
• Revisiting the National Institutes of Health Fair Pricing Condition: Promoting the Affordability of Drugs Developed With Government Support (Annals of Internal Medicine)
• Manufacturing Standards for Biopharmaceuticals: A Conversation with NIST’s Sheng Lin-Gibson and Vijay Srinivasan (NIST)

• FDA Advisory Committee Calendar
• Hearing On “Improving Safety And Transparency In America’s Food And Drugs” – 29 January 2020
• Public Meeting - Food and Drug Administration’s Communications About the Safety of Medical Devices – 1 April 2020

• Categorisation of antibiotics used in animals promotes responsible use to protect public and animal health (EMA)
• Merck invests 250 million euros in Swiss biotech facility (PharmaLetter-$)
• NIHR to invest £59m in AMR, air pollution and infectious diseases (PharmaTimes)
• Advertising investigations: December 2019 (MHRA)
• MHRA: policy for handling conflicts of interest (MHRA)
• Professional use defibrillator/monitor: all HeartStart XL+ (Model number 861290) - risk of failure to deliver therapy (MDA/2020/003) (MHRA)

• Cipla, PAG eye Wockhardt’s formulations business (Economic Times)
• Indian pharma industry likely to grow at 10-13 per cent in FY'21: Icra (Economic Times)
• CDSCO releases list of 139 reference products to conduct BE studies (Pharmabiz)
• CDSCO strengthens oversight of clinical trials, 145 trials inspected in 3 years (Pharmabiz)

• Congressman whose committee oversees US health agencies questions China’s coronavirus reporting (CNBC)
• Ex-FDA chief worries China could be underestimating coronavirus cases by ‘tens of thousands’ (CNBC)
• Murray, Democrats Press Health Department for Updates on Novel Coronavirus, Call for Continuing Robust, Science-Driven Response (Senate HELP)
• CDC urgently working to make coronavirus lab diagnostic available (MedtechDive)
• WHO chief and Xi discussed protection of Chinese, foreigners: WHO (Reuters)
• 3M CEO: ‘We’re going 24/7’ to ramp up production of masks to meet coronavirus demand (CNBC)
• Confusion and lost time: how testing woes slowed China's coronavirus response (Reuters)
• Beijing city reports first coronavirus death: state TV (Reuters)
• Taiwan reports first case of domestic coronavirus transmission (Reuters)
• EU says could assist with repatriations as coronavirus spreads (Reuters)
• Germany plans to evacuate citizens from Wuhan: Der Spiegel (Reuters)
• Man in Germany contracts coronavirus in one of first cases of transmission outside China (Reuters)
• Japanese coach driver who met Wuhan tourists catches coronavirus: ministry (Reuters)
• Sri Lanka confirms first case of coronavirus: health official (Reuters)
• The coronavirus questions that scientists are racing to answer (STAT)
• Bayer to donate medicines and money with a total value of approximately EUR 1.5 million (Press)

• What drugmakers should consider when accessing the Latin American market (PharmaLetter-$)

• Genomics experts dispute nine genes linked to congenital heart condition (NIH)