Recon: BioMarin Eyes $2-3M Price for Hemophilia Gene Therapy as Other Gene Therapies Test Europe’s Willingness to Cover Them

• BioMarin Explores Pricing Experimental Gene Therapy at $2 Million to $3 Million (WSJ)
• Neon Therapeutics makes one last retreat, selling itself cheap in a bargain basement M&A deal (Endpoints) (BioPharmaDive)
• Hedge fund veteran looks to cash in on biotech boom (Financial Times)
• Pharma execs pitch ideas at JPM to lower drug costs. None include dropping their own prices (CNBC)
• A court struck down a ban on pharma ‘price gouging.’ One state wants to revive it — and others could follow (STAT)
• Verily tangos at JPM with a health tech partner — and steps on a few toes (STAT)
• FDA panel says ’no’ to another new opioid (Politico) (Press)
• The kill-switch for CRISPR that could make gene-editing safer (Nature)

• Gene therapies test Europe’s willingness to pay (Financial Times)
• Biopharma's China plan gets a boost from patent protections sealed in now official trade deal (Endpoints) (Pharmafile) (Law360-$)
• Three African nations roll out first malaria vaccine in closely watched trial (STAT)
• Celltrion to build plant in China (Yonhap)
• NICE ‘OK’ for Lynparza (PharmaTimes)
• HIV infections among gay and bi men fall by 71% in UK (BBC)
• Japan confirms first case of infection with new China coronavirus (Reuters) (Japan Times)
• Comparator Report on Cancer in Europe 2019 (EFPIA)
• Policy Proposals to Minimize Medicine Supply Shortages in Europe (EFPIA)
• Upward trend in market entry of high-cost drugs for rare diseases shows no sign of abating (Health Canada)

• GSK, Pfizer contradict on the future of consumer health JV — report (Endpoints)
• New AMR Report Is ‘A Wake-Up Call’, Says Industry Body (Pink Sheet-$)
• Richard Pazdur: 20th Anniversary Edition (Pink Sheet-$)
• US generic drug supply chain continues to shrink (Pharmacompass)
• Lilly ends $1.4bn deal with immuno-oncology biotech NextCure (PMLive)
• How Moderna is using Amazon cloud to produce personalized cancer vaccines (CNBC)
• Analysts tip Biogen to file for aducanumab approval within weeks (Fierce)
• Astellas Completes Acquisition of Audentes Therapeutics (Press)
• An Overview of FDA OPDP Enforcement for 2019 (Eye on FDA)
• Kite Pharma adds year before commercial production begins at Urbana site (Frederick News-Post)
• Biosimilar and Biologic Business Developments Update – Collaborations and Licensing Deals (Big Molecule Watch)
• Express Scripts Could Negotiate Drug Rebates For 100m Lives With Prime Therapeutics Deal (Scrip-$)
• JPM20: Orchard isn't for the picking, Biohaven's Allergan headache, and who's on Vascepa? (BioPharmaDive)
• JPM: A Humira-beating $20B in sales from Skyrizi and Rinvoq? It's possible, AbbVie CEO says (Fierce)
• Novartis' David Lennon on next steps for AveXis, selling Zolgensma's price to the public (BioPharmaDive)
• #JPM20: Five years after first PCSK9, Novartis goes for win as Sanofi moves on, Amgen salvages what's left (Endpoints)
• Frazier closes 10th fund in 30 years, with $617M to bet on cell/gene therapy, Big Pharma spinoffs and more (Endpoints)
• #JPM20 exclusive: Olivier Brandicourt follows the Big Pharma CEO path to private equity, joining Blackstone ahead of a mammoth fund debut (Endpoints)
• #JPM20: After Year of NASH collapses, all eyes on two biotechs (Endpoints)
• US FDA's Decade In Review: From Biosimilars To Real-World Evidence (Pink Sheet-$)
• Enhancing the pharmaceutical supply chain with big data (Pharmaceutical Manufacturing)

• Neuroptika Announces Enrollment Of First Patient In Phase 2 Clinical Trial For Dry Eye Disease (Press)
• First Patient Dosed with Cellectis’ New Allogeneic UCART123 Product Candidate for Relapsed/Refractory Acute Myeloid Leukemia (Press)

• Health IT to lead 2020 deals, KPMG predicts (MedtechDive)
• Foundation Medicine touts concordance ahead of 1H FDA ruling on liquid biopsy test (MedCityNews)
• ResMed pays $37.5M to settle false claims allegations (MedtechDive)
• REVA files for bankruptcy after bioresorbable scaffold flops (MedtechDive)
• Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee (FDA)

• How Anti-Vaccine Activists Doomed a Bill in New Jersey (NYTimes)
• FDA Says That Theranos Discovery Strain Is Causing Other FDA Enforcement Efforts to Take a Backseat (FDA Law Blog)
• Genentech, Inc. v. Hospira, Inc. (Fed. Cir. 2020) (Patent Docs)
• Another Good Pradaxa Preemption Ruling—This One In California (Drug & Device Law)
• Gov't Initiatives May Boost Health Coverage For Genetic Tests (Law360-$)
• GSK Seeks To Forgo Trial In First Zofran MDL Bellwether (Law360-$)
• Bayer Says 27K Essure Suits Can't Head 'Full-Steam' To Trial (Law360-$)
• UnitedHealth bets on government health plan growth in 2020 (Reuters)

• FDA Advisory Committee Calendar
• Good Clinical Practice Symposium (Commercial) 2020 – 13-14 February 2020
• Public Workshop - Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine – 5 March 2020

• Germany joins the 1+Million Genomes Initiative (EC)
• EMA welcomes new Head of Information Management Division (EMA)
• LC and GC columns in monographs (Council of Europe)
• Breast cancer patients to have further NICE-approved drug combination option on Cancer Drugs Fund (NICE)
• Janssen submits Spravato expansion in EU (PharmaTimes)
• Convex two-piece skin barriers (Natura /Surfit/Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier (MDA/2020/002) (MHRA)

• Aiming for an IPO, Antengene wants to be China’s Celgene (PharmaLetter-$)

• Wockhardt gets DGCI approval for 2 new antibiotics (Economic Times)
• PMP set to promote domestic production of medical devices (Economic Times)
• Strides gets USFDA nod for anti-allergic drug (Economic Times)
• A Decade’s Deals In Indian Pharma Point To 2020 Trends (Scrip-$)
• Gujarat leads in collection and analysis of drug samples with 13,616 samples tested last year (Pharmabiz)

• Health Products Regulation Group: Regulatory Science Strategy, 2020-2025 (TGA)
• TGA presentations: The 2nd Industry Forum on Good Manufacturing Practice (GMP), 21 November 2019 (TGA)

• Hanan Sboul takes over the position of IGBA Chair (IGBA)
• Public-Private Collaboration Commits to Accelerate Access to Health Services in Africa, Reaching 1.7 Million People (Press)

• Blood Pressure Patterns Are Different for Women (NYTimes)