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Headlines > January 2017

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Indian clamps down on OTC antibiotic sales to stem spread of superbugs

16-Jan-2017 - The CDSCO has urged pharmacies to stop selling prescription antibiotics over-the-counter in an effort to slow the spread of antimicrobial resistance.

EFPIA and ABPI urge UK to keep drug regs consistent with EU post Brexit

16-Jan-2017 - Industry groups have reiterated calls for UK drug approval and safety laws to be kept in line with EU rules, arguing that consistency benefits governments and patients Europe-wide.

MannKind ‘aggressively’ moving forward with inhalable epinephrine

16-Jan-2017 - MannKind Corporation met with the US FDA last month to discuss a single-use disposable epinephrine inhaler it says could be an affordable alternative to the Epipen.

update

Trump vows to bring drug production back to US

12-Jan-2017 - President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines. 

PEOPLE ON THE MOVE

Hiring and Firing Jan '17

12-Jan-2017 - Welcome to in-PharmaTechnologist's monthly round up of who's been moving where in the small-molecule manufacturing world. The CEO of BMS is moving internally, Axim Biotechnologies and Pharmalink have new board...

US FDA finalises combination drug/device product guidance

12-Jan-2017 - The US FDA has finalised its guidelines on cGMP and quality system compliance for drug and delivery device combination products.

Aerie to build manufacturing facility in Ireland

11-Jan-2017 - Aerie Pharmaceuticals Inc will lease a 30,000 sq ft manufacturing facility in Ireland to commercialise its eye-drop product for Glaucoma after delays at a third party CMO.

Catalent to assess resveratrol formulation across softgel platforms

11-Jan-2017 - Catalent will assess Jupiter Orphan Therapeutics’ resveratrol across its softgel technologies in an effort to improve the bioavailability of the rare disease candidate.

T-ray technique faster for tablet quality and structure testing say researchers

11-Jan-2017 - High frequency radiation can be used to test tablet quality and structural characteristics on the production line according to scientists planning to develop low cost THz sensors. 

Trump names chair of vaccine commission to examine 'scientific integrity'

10-Jan-2017 - President-elect Donald Trump has asked noted vaccine skeptic Robert F. Kennedy Jr. to chair a commission to investigate vaccine safety.

Day 2

JP Morgan Conference: Trumpcare, moonshots and M&A

10-Jan-2017 - If you're not going to San Francisco, in-Pharmatechnologist brings you a smattering of the best tweets from the 35th Annual JP Morgan Healthcare Conference.

Proveca hires Quotient unit to develop more kid-friendly formulations

10-Jan-2017 - Quotient Clinical has been hired to develop child-friendly formulations of several off-patent drugs by Proveca Ltd.

Novo Nordisk hires Fluor to build giant US diabetes drug API plant

10-Jan-2017 - Novo Nordisk has hired Fluor Corporation to design and build the diabetes drug API plant it is setting up in Clayton, North Carolina.

Danish regulators ban Europharma DK ApS and suggest firm needs new CEO

09-Jan-2017 - Danish regulators have banned Europharma DK ApS from making or importing medicines and drug intermediates after identifying serious breaches of GMP at its plant in Esbjerg.

Aurobindo to add Portuguese capsule and tablet capacity through Generis Farmaceutica buy

09-Jan-2017 - Aurobindo Pharma Limited has agreed to buy Portugal-based Generis Farmaceutica SA for €135m in a deal that includes a tablet and capsule plant in Amadora.

US DEA finalises controlled substance and equipment revisions

09-Jan-2017 - Drugmakers must include a transaction identification number when buying or selling machinery for tabletting or encapsulating controlled substances, according to a final ruling from the US DEA.

Patented biosynthesis produces 'authentic, standardized cannabinoids' for pharma

05-Jan-2017 - Teewinot’s Irish subsidiary has been granted a fourth patent for a pharmaceutical cannabinoid manufacturing technique which it says saves both time and money.

Out with the old, in with the new? Lonza sells peptide biz, Recipharm adds Indian ops

05-Jan-2017 - Recipharm receives approval to buy Kemwell’s Indian operations and PolyPeptides completes the acquisition of Lonza’s peptide business. Welcome to in-Pharmatechnologist’s 2017 M&A round-up.

Shire offloads mRNA tech and staff to RaNa Therapeutics

05-Jan-2017 - Shire has sold its MRT messenger RNA platform to RaNA Therapeutics but will retain an equity stake in the Cambridge, Massachusetts-based biotech.

Intarcia receives $140m Gates Foundation grant for needle-free HIV tech

04-Jan-2017 - The Gates Foundation has invested $140m in Intarcia Therapeutics Inc to develop the biotech’s needle-free delivery pump for use with an HIV prophylactic therapy.

Data integrity and aseptic issues land Wockhardt with FDA warning

04-Jan-2017 - A Wockhardt facility in India put under import alert last year has received a US FDA warning letter citing issues ranging from data discrepancies to inappropriate aseptic clothing.

Prokarium and Probiomed team to scale-up thermostable oral vaccine

04-Jan-2017 - The project funded by the UK and Mexican governments will look to prove the scalability of Prokarium’s oral vaccine platform, the firm says.

Fire at Sun Pharma API factory kills two

04-Jan-2017 - Late last week, a fire at Sun Pharmaceutical Industries Limited’s Ahmednagar factory, which manufactures APIs, sent four employees to the hospital.

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