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)

WHO Officials Offer Opposition to Value-Based Drug Pricing

Officials from the World Health Organization (WHO) told reporters at an information session on Thursday that the agency has serious reservations at prices based on pharmaceutical prices.

"What is the value of life? This structure is good for luxury items, because you have a choice ... if I am sick of cancer, what is the choice? We believe value-based pricing is impossible for products that are indispensable, "said Marie-Paule Kieny, Deputy General Manager of Health Systems and Innovation, which he said.

Value-based fixing systems, such as the UK's National Institute of Health Care, decide what is price-paying and price-adjusted. In general, NICE estimates that interventions costing the National Health Service in the UK less than £ 20,000 ($ 26,000) per year of QALY are cost-effective.

Kieny spoke after a meeting of about 200 stakeholders from countries around the world in the first Just One Day Forum in Amsterdam this week sponsored by WHO and the Ministry of Health, Welfare and Sport of the Countries -Bas.

He called on countries to increase transparency in drug prices because "countries sometimes think they have the best deal and if too many countries believe, there is no movement or exchange of information ".

And although Kieny acknowledged that "innovation is not free," he also said the discussions should focus on "the real cost of R & D [research and development]" and the cost of failure, As well as set up price systems that a payer is willing to pay.


A new study published this week on the cost of anticancer drugs found worldwide that even though prices are the highest in the US, are the least affordable in India "by a large margin. "Despite falling prices, anti-cancer drugs are less affordable in middle-income countries than in high-income countries.

. Dr. Suzanne Hill, Director of Essential Medicines and Health Products WHO Kieny reiterated points about value systems, adding, "Who decides what value? He also said that the forum "is our first attempt to launch a program of action to understand the factors that determine the current structure of prices are."

He insisted on the forum of interest for collaboration between governments in "scrutinizing the horizon" or evaluating products in the industry for what is important and what is worth paying in the future , And the need for WHO to develop a list of vulnerable essential drugs. Like those of scarcity all over the world.

UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

No one knows what is going to look like British pharmacovigilance after the UK left the EU and uncertainty puts many residents qualified person responsible for pharmacovigilance (QPPV) in the UK in a precarious situation.

According to the independent academic research unit on drug safety in the UK, which met last week on the subject of pharmacovigilance post-Brexit "At worst, it will cause a serious blow to British pharmacovigilance" as the Pharmaceutical companies "will not be required to carry pharmacovigilance in the UK and can not be expected to pharmacovigilance providers from the UK to carry out these studies."

Currently, the European Medicines Agency (EMA) runs the Pharmacovigilance Risk Assessment Committee (PRAC), which uses two members from each Member State and has been chaired since its inception in 2012 by the Agency June Raine regulation of medical products And UK Health (MHRA).

But after Brexit, the UK will not show PRAC, although representatives may present as non-voting observers, as Norway and Iceland do now.

"Pharmacovigilance is above policy," said Saad Shakir, director of the Research Unit on drug safety, last week at the "UK Pharmacovigilance Forum post-Brexit" according to the audio files sent By email to focus.

He also noted the large number of QPPV leaders based in the UK, adding: "We want them to remain part of the EU apparatus. These are national assets." But now, he said, they were "afraid of what is going to happen as the regulations indicate that QPPV should reside in the EU."

Shakir said he could have negotiated a mutual recognition system or a means for EMA and MHRA to continue collaboration.

Ian Hudson, general manager of the MHRA since 2013, said recently, according to Shakir, there had been some discussion about outsourcing regulation work in the UK, but "We do not know what this will look like en -traitance."

Virginia Acha of the British Pharmaceutical Industry Association also noted that pharmacovigilance times at the short end of the rod, as it works so well now.

"There is an enthusiasm to maintain most of the status quo, but the extent to which it is possible to publish Brexit is unclear," the Drug Investigation Unit said in a statement. "Once the UK leaves the EU, it is essential that the current UK-Europe cooperation in pharmacovigilance has improved a lot. Mutual recognition of market research and MHRA EMA is required as part of the Brexit negotiations. "

In addition to this meeting focused on UK pharmacovigilance, last weekend, the European Council established guidelines for the Brexit negotiations between the UK and the European Union.