Regulatory Recon: FDA Approves Humira for 10th Indication; Unproven Stem Cell Centers Spreading Across the US (1 July 2016)
Headlines: US
- The clinics offer stem cell therapies unproved proliferate throughout the US (MIT Technology Review)
- copay coupons was making more expensive drugs? (ProPublica)
- FDA promises faster to the drug GMP warning letters shorter (Gold $ Detailed)
- Breakthrough therapies: FDA Official calls for greater transparency in nominations, Denials (Focus) ($ scriptures)
- Doctors, hospitals Americans paid billions for the drug, device manufacturers: the government (Reuters) (MassDevice)
- Fireproof: CRISPR takes the next step (bill Harvard Health)
- FDA warns Two Chinese medicines manufacturers for data integrity violations (Focus)
- Call for action on toxic chemicals (New York Times)
- A final medical school in the United States, even killed the animals to teach surgery. But no more. (Washington Post)
- The FDA issued new guidance on project Elemental Impurities (Focus)
- FDA approves Humira for non-infectious intermediate and posterior adults Panuveitis few weeks before Biosimilars Advisory Committee (Press) (Advisory Committee meeting)
- The difference between manufacturing and design defects (medications and right of the device)
- Reshaping the FDA Purpose To prepare the 'avalanche' of products cancer of senior officials (Forbes)
- The consequences for public health of updating the FDA to label drugs abortion (bio issues and blog)
- FDA approval at the barricade Place trajectory of the novel Cholesterol Drug (CardioBrief)
- More US babies with birth defects related Zika reported by the health agency (Reuters)
Headlines: International
- The final text travel by first impressions (MedicalDevicesLegal)
- Brexit: Guests find positives scientists (Financial Times)
- action plan to combat illegal therapies with fresh cells (Swissmedic)
- Swissmedic informs the risk of cervical cancer in women treated with Remicade and biosimilars (Swissmedic)
- AstraZeneca sells the rights to two dermatological drugs LEO Pharma (Reuters)
- WHO urges manufacturers to submit products for malaria prequalification scheme (WHO)
- UK regulatory approvals for testing medications stops cabinet of India (Reuters)
- Vaccine anti-couple found guilty in the death of young children should post on Facebook decision (vice)
- database sheds light on pharmaceutical payments to British doctors (Financial Times)
- Doctors want more details on labeling of biosimilars (GABI)
- Health officials to prevent yellow fever Congo career disaster (Reuters)
USA .: Pharmacy and Biotechnology
- International Supply Chain Pharmaceutical endangered as never before: Summary Webinar (FDA Law Blog)
- Top 5 winners and losers from Q2 2016 Biotech (Forbes)
- KaloBios emerges from bankruptcy, raises $ 14M in the recapitulation (fierce)
- NIH refused to march again in regulation and Human Challenge National Academies (Genomics Law Report)
- efforts by the NIH application uses scientific methods to reduce HIV transmission from mother to child (NIH)
- FDA to keep the workshop of PPE (BioCentury)
- Family history major predictor of heart attacks in people with psoriasis (Reuters)
- Advaxis manufacturing, security and development of key cancer drugs efficacy (BioPharmaReporter)
- Mother throws Serve daughter and others with poorly understood non-profit (Forbes)
- Update: The first clinical trials with live biotherapeutic: chemistry, manufacturing and control of information; Guidance for Industry (FDA)
- Bioequivalence recommendations paliperidone palmitate; Draft Guidance for Industry; Availability (FDA)
- Vulvovaginal candidiasis: drug development for treatment; Draft Guidance for Industry; Availability (FDA)
- Recurrent cold sores: the development of drugs for the treatment and prevention; Draft Guidance for Industry; Availability (FDA
United States: pharmaceutical and biotechnology products: results of clinical studies, documents and Designations
- The first patients included in the study post-approval Orberá US intragastric balloon (press)
- Phase III data: Merck KGaA Erbitux plus FOLFOX improved results in RAS wild-type metastatic colorectal cancer ($ PharmaLetter-)
Medical devices in the US:
- Turning FDA guidance Panels Project NGS (GenomeWeb)
- FDA panel for approval Medite OTC Factors Diagnosis of Infectious Diseases (detailed $ Gray)
- Sparo laboratories obtains FDA approval for its application connected monitor lung function, Ala (mobihealthnews)
United States: Assortment and government
- Warnings other prescription drugs making Preemption (Drugs and right of the device)
- PerkinElmer Faces game over 'Lousy' drug testing devices (Law360a- $)
- FDA fifth biennial report situation Judicious use of antimicrobials in food-producing animals (FDA)
- Federal Judge blocks law on abortion Indiana (Reuters)
Upcoming Meetings and Events
- Calendar of the Advisory Committee of the FDA
- Webinar - Update on the program of medical devices FDA clinical trials - July 14, 2016 (FDA)
- Provisional agenda: Part 15 Audience: Draft Guidelines for the regulation of cells, tissues or cell or tissue products based on September 12, 2016 (FDA)
Europe
- EMA: Strengthening interaction with the academic world (EMA)
- BIOTRONIK wins CE Mark for EDORA adaptive pacemakers MRI (MassDevice)
- Factors UK MHRA regulatory human Expectations Directive is aligned with the United States ($ CLINIC-)
- SRS Medical wins CE Mark for prostate Key stent (MassDevice)
Asia
- China expects the market for organic products in the fastest growing in the next decade (BioSpectrum)
India
- Torrent Pharma acquires Glochem unit in Vizag (Economic Times)
- Biosimilars are too expensive and do little to improve accessibility: Doctors (Economic Times)
Australia
- Fees and charges: Summary - July 1, 2016 (TGA)
Canada
- Draft Guidance Document - Canceling a Drug Identification Number (DIN) and notification of interruption marketing (Health Canada)
Zika
- The Zika fears are growing among women in the US ($ WSJ-)
General health and other interesting items
- US Transgender Estimated population doubles to 1.4 million adults (New York Times)
