Recon: Roche’s Genentech Strikes Deals With Skyhawk, Sosei Heptares and Convelo Therapeutics

• How pharma, under attack from all sides, keeps winning in Washington (STAT)
• 2020 candidates throw punches at drug industry (Politico) (BioPharmaDive)
• Democrat Harris unveils plan to lower drug costs, put 'people over profit' (Reuters) (The Hill) (Washington Examiner) (Harris)
• Democratic chair: Medicare negotiating drug prices not moving before August (The Hill)
• AI Drug Hunters Could Give Big Pharma a Run for Its Money (Bloomberg)
• Roche's Genentech goes on deal spree, unveiling third deal on the same day (Endpoints)
• Sosei Heptares pens $1B biobucks GPCR pact with Genentech (Fierce) (Endpoints)
• Skyhawk Inks Deal With Genentech for Cancer and Neuro Drug Discovery (Xconomy) (Endpoints)
• J&J warns of hit from generic drugs in third quarter, shares fall (Reuters) (CNBC) (Financial Times)
• Gilead's Kite builds cell therapy manufacturing quickly even as Yescarta sales grow slowly (Fierce) (Endpoints) (Press)
• Abbott to hike production of lower-cost glucose monitors as diabetes soars (Reuters)
• FDA starts speedy review of Novartis’ sickle cell antibody (PMLive) (Endpoints) (Press)
• Judge reduces Bayer Roundup verdict to $25m from $80m (Financial Times)

• Hear best practices to help you save time, improve system adoption, and keep your project on track from kick-off through post-deployment. Join us on July 30 at 11am ET/8am PT.
• Register today.

• UN wants more urgency in AIDS fight as gains and funding fade (Reuters)
• First Ebola patient in eastern Congo's main city dies (Reuters)
• Canada police probing 'possible policy breaches' at National Microbiology Lab (Reuters)
• Free of Pfizer, AM-Pharma raises €116M for phase 3 (Fierce) (Endpoints) (Press)
• Drug-related deaths in Scotland rise 27% (Financial Times)
• GSK took a leap of faith on PARP inhibitors in cancer. It may pay off (STAT)
• Takeda's translational cell therapy group revs up for a race to the clinic with off-the-shelf CAR-T (Endpoints)

• FDA contributes to hunt for new heart failure endpoints (Fierce)
• The Bottom of the Stem Cell Barrel (In The Pipeline)
• Op-Ed: Ask whether a drug works before worrying about what it costs (LA Times)
• Why Isn’t Insulin a Complex Generic? PA Representative Asks FDA (Focus)
• H1 analysis: The high-stakes table in the biotech deals casino is paying out some record-setting winnings (Endpoints)
• What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains (Focus)
• The opioid drugs scandal is depressingly familiar (Financial Times)
• Dsuvia: A Dull US FDA Review Preceded The Controversial Approval (Pink Sheet-$)
• US FDA Compounding Oversight: Not As Bad As FDA Makes It Sound? (Pink Sheet-$)
• Generic Drug Application Submission Downturn Continued In June (Pink Sheet-$)
• Part club, part guide, part landlord: Arie Belldegrun is blueprinting a string of bespoke biotech complexes in global boomtowns — starting with Boston (Endpoints)
• HIV’s genetic code, extracted from a nub of tissue, adds to evidence of virus’ emergence in humans a century ago (STAT)
• San Diego ophthalmic biotech upstart raises $28M on alternative to corneal transplant (Endpoints)
• What They Said – FDA Press Releases First Half 2019 – B.G and A.G (Before Gottlieb/After Gottlieb) (Eye on FDA)
• Enlisting CRISPR in the Quest for an HIV Cure (NIH)
• Evoke taps new president for North America, continues talent expansion (Fierce)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses (FDA)
• Determination That MIOCHOL (Acetylcholine Chloride Intraocular Solution), 20 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

• Seattle Genetics and Astellas Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer (Press)
• Athira Pharma Presents Preliminary Results from Phase 1 Trial of NDX-1017 at Alzheimer's Association International Conference 2019 (AAIC) (Press)
• Cancer Targeted Technology Commences Phase I Clinical Trial in Prostate Cancer Patients with an Innovative Radiotherapy, CTT1403, and Receives a $3.2M NIH Grant to Fund the Trial (Press)
• Axial Biotherapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of AB-2004 for Treatment of Gastrointestinal Dysfunction and Associated Behavioral Symptoms of Autism Spectrum Disorder (Press)

• FDA Looks for New Device Sterilization Methods (Focus)
• Will Medtech Rise to FDA's Sterilization Challenge? (MDDI)
• Boston Scientific aims for personalized Parkinson’s therapy with Vercise DBS (MassDevice)
• Class 1 Device Recall HUDSON RDI NEONATAL ConchaSmart Breathing Circuit (FDA)
• Novian Health Obtains CE Mark for Novilase Breast Therapy (Press)

• Opioid 'kingpin' J&J fueled epidemic, Oklahoma argues at trial's end (Reuters)
• State drug importation programs will work with the FDA, not outside of it (STAT)
• Rick Scott: PhRMA hasn't provided 'a single answer' on lower drug prices (The Hill)
• Following ‘CRISPR babies’ scandal, senators call for international gene editing guidelines (STAT) (Feinstein)
• Medicare Advantage Overbills Taxpayers By Billions A Year As Feds Struggle To Stop It (KHN)
• Medicare: Limited Information Exists on the Effects of Synchronizing Medication Refills (GAO)
• Massachusetts Requires Expert Testimony for Pharmacist Malpractice Claim (Drug & Device)

• FDA Advisory Committee Calendar
• Hearing On "Oversight Of Federal Efforts To Combat The Spread Of Illicit Fentanyl" – 16 July 2019

• Exporting active substance manufactured in the UK in a no deal Brexit (MHRA)
• ‘UK Waiver’ For SPCs Proposed In Case Of No-Deal Brexit (Pink Sheet-$)
• As of 1 January 2020 the eCTD is mandatory for ALL CEP applications including notifications, revision, renewal and new applications (Council of Europe)
• EMA Warns of Dosing Errors With Methotrexate Drugs (Focus)
• MHRA Seeks Input on Patient, Public Engagement (Focus)

• How an Indian tycoon fought Big Pharma to sell AIDS drugs for $1 a day (Quartz)
• Cipla forms JV with Jiangsu Acebright for respiratory medicines in China (Economic Times)
• Experts laud new regulations for clinical trials to make human studies patient-science-centric (PharmaBiz)
• Maha FDA asks IDMA, IPA and OPPI to upload information related to licenses on SUGAM portal urgently (PharmaBiz)
• CDSCO to bring in sweeping changes to make regulatory procedures more transparent and speedy: Dr S Manivannan (PharmaBiz)

• Canada: National Pharmacare Or ‘Fill The Gaps’? (Pink Sheet-$)

• Views Differ On Australian Proposal To Link Review Of CDx With Drugs (Pink Sheet-$)

• Regulations That Mandate Sepsis Care Appear To Have Worked In New York (NPR)