Regulatory Recon: Kite CAR-T Therapy Nabs FDA Priority Review;

Regulatory Recon: Kite CAR-T Therapy Nabs FDA Priority Review; UnitedHealth, Merck Sign Pact to Explore Value-Based Payments (26 May 2017)

 Focus: United States

• UnitedHealth and sign agreement to explore Merck's Linking Drug Performance Payments (CNBC)
• Impulse Industry: Excess Aging Background Lines Imposed (BioPharmaDive)
• Kite Receives Priority Review of FDA for Treatment of RCA-T for Aggressive Non-Hodgkin's Lymphoma (Press)
• The mortality rate of Alzheimer's disease in the United States has increased dramatically in 15 years. Why? (Washington Post) (Reuters)
• Gottlieb: FDA hiring froze, plans to increase competition from generics come (Focus)
• Generics Copaxone: Who will win the first exclusive affiliates? (Warning)
• FDA Panel supports Epogen biosimilar Hospira 14.01 Vote (Focus)
• The reporter lodged a complaint against the FDA's approval for Sarepta (Boston Biz Journal)
• One quarter of American babies with congenital malformations related to Zika was born in New York (NYTimes)
• The proposed budget would reduce Trump's $ 2.2 billion in global health spending (NPR)
• The J & J USA game is not likely to be above the OTC (pink information-$) (Fierce)
• HHS action on drug prices: here is the price of the secretary who is listening (Rose- $)
• Biosimilar advisory committees remain smoother, even with regard to Lo Mismo (leaf Rosa- $) remain
• As the FDA seeks to speed up the review of two other political experts want to limit drug prices accelerated win an OK (Endpoints)
• Drug addiction experts questioned the suggestion to limit FDA opioid prescriptions (Modern Healthcare)
• SURVEY: Medical device manufacturers to be pirated wait, but few do anything (MassDevice)
• Big pharmaceutical and social media: how to avoid problems with the FDA (Forbes)
• Two years later, what has Apple achieved ResearchKit? (STAT)

Approach: International

• Update of the seventh session of the World Health Assembly on 25 May (WHO)
• uperbugs in the supply chain (Pharmafile)
• The German pharmaceutical market has established stable growth (PMLive)
• SMEs Leverage the EU's centralized procedure and scientific support EMA (Pink information- $)
• The plan that generic drugs Modi worries health experts, the Indian pharmaceutical sector (Reuters)
• The former Americans. Of AbbVie. Humira's sales are on the edge of the precipice. Analysts (Fierce), but no panic, say
• movement of the multinational pharmaceutical industry to stop generic registration before the patent in Russia (PharmaLetter- $) occurs
• Tip-Toes FDA in China to push data integrity, harmonization (Rosa sheet $)
• Three negative opinions of the CHMP - but who received an advantage? (SCRIP- $)
• India Cipla low investment in biopharmaceuticals, sharpens focus on breathing (Reuters) (Endpoints)
• Why biosimilars are changing the pharmaceutical industry (EPR)
• The FDA and EU supply chains have doubled inspection of Asian pharmaceutical products (pink information- $)
• Clinical studies conduct: China steps to facilitate the entry of new drugs (color Pink Leaf- $)

Pharmaceuticals and biotechnology

• Harpoon Therapeutics reaches $ 45 million in series B for work I-O (Fierce)
• the Celgene oncology head on ASCO, Revlimid, and the increase in the value of triplet combinations (PharmaLetter- $)
• Safety Profile ozanimod help to bring to the market multiple sclerosis, says Celgene (Fierce)
• FDA Drug Safety Podcast: The FDA does not identify any adverse effects to date with brain retention of gadolinium-based contrast agents for magnetic resonance imaging; Continuation Review (FDA)
• The market for ovarian cancer drugs (Nature)
• Shire quietly stops new investments leaving Baxalta Ventures (Boston Biz Journal)
• Rendezvous: FIIM, Merck, Chromocell, Kymab, GW Pharmaceuticals, Fix Fortuna and Pattern (SCRIP- $)
• AstraZeneca has launched a nationwide voluntary recall of a batch of BRILINTA 90 mg professional sample bottles due to report another drug in a bottle of this batch (press)
• Patient Partnership Group Rare Disease Options Cell Business Model / Gene Therapy (SCRIP- $)
• Constellation Pharmaceuticals Hires Jigar Raythatha as CEO (PharmaLetter- $)
• Does the FDA change its interpretation? (FDAZilla)

Pharmaceuticals and biotechnology: study results, deposits and denominations

• Chronology delayed by Raxone Santhera in DMD (BioCentury)
• Abeona Therapeutics receives orphan designation from the FDA for gene therapy (PRT)
• Anika announces the first patient enrolled in an additional phase III trial of CINGAL for the treatment of knee pain associated with osteoarthritis (press)

Medicalequipments

• New roles for medical devices in the fight against antibiotic-resistant superbugs (MDDI)
• Blood-based breast cancer screening can help prevent biopsy (Forbes)
• Most counterfeit contact lenses are contaminated, according to the FDA (Industry Securing)
• Ethicon J & J states the economic analysis of data in Dermabond Prinéo (MassDevice)

United States: Assortment and Government

• At Trump's initiative, states are trying to include Medicaid in conservative directions (Washington Post)
• Extended causal fault condemns another failure with claim (drugs and devices Act)
• n the race to develop telemedicine services, be aware of legal problems (MDDI)
• Mylan Institutional LLC v. Aurobindo Pharma Ltd. (Fed. Cir. 2017) (Patent Docs)
• The Consumer Advocates Coalition Challenges Notifications FDA's Final Rule GRAS (FDA Blog Law)
• The "quick search" of health care: foundations help consumers maintain a balance and a mirror for the health system (Health Affairs blog)
• Patients trio continues Pfizer, Bristol-Myers, claiming they suffer Eliquis soft pedal strap (fierce)
• Biogen Asking the Judge to File Negative Antitrust Drug Lawsuit ($ Law360-)
• Pfizer said the expert testimony in the game that Celebrex unreliable ($ Law360-)

Upcoming dates and events

• Schedule of the FDA Advisory Committee
• Subcommittee on Advisory Committee on Pediatric Oncology on drugs; opinion
• Meeting - 21-22 June 2017
• Advisory Committee on Vaccines and Related Biological Products; Notice - July 28, 2017

Europe

• Hepatera: PRIME eligibility scheme for Myrcludex B by the European Medicines Agency (Press)
• Patient safety in the NHS: culture change agents (Harvard patent of health)

Asia

• Chinese group buys James Bond brand condominiums (Bloomberg) ($ Law360-)

India

• Diagnosis agappe dressed Hitachi Chemical Company (Economic Times)
• Government identifies ADR 9 additional centers in district hospitals to expand PVP in the country (Pharmabiz)

Australia

• Reference: Examine 75 standard cells derived from TGO cord blood progenitor hematopoietic (TGA)
• tablets 10 mg BTC rosuvastatin - Reminder (TGA)
•  BTC Paracetamol Tablets - Reminder (TGA)
•  Valium (diazepam) tablets 5 mg tablets blister of 50 tablets - Reminder (TGA)
•  Apotex pantoprazole tablets 40 mg - Reminder (TGA)

Another international

• Brazilian doctors use fish skin to treat burn victims (Reuters)
• General health and other interesting items

Symptoms of celiac disease are more likely to be resolved in children (Reuters)
Michael Bliss, a historian who misspelled the myths of insulin discovery, died at 76 (New York Times)