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Headlines > June 2017

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Patheon to spend $45m on manufacturing plants ahead of Thermo takeover

30-Jun-2017 - Patheon NV has announced it will spend $45m to expand and enhance its manufacturing network citing customer demand for more reliable, flexible and cost-efficient supply chains.

Microneedle patch stable, painless and simple say researchers

29-Jun-2017 - The team behind a microneedle patch designed to administer influenza vaccines say it has increased thermostability compared to needle and syringe immunisation methods.

PE firms' plan to take AMRI private on track

29-Jun-2017 - The Carlyle Group and GTCR LLC are poised to complete the takeover of Albany Molecular Research (AMRI) after the early termination of the mandatory waiting period that covers such deals...

Opiant has new Narcan nasal spray patent listed in US FDA orange book

29-Jun-2017 - Opiant Pharmaceuticals says it has strengthened its IP position for the emergency opioid overdose treatment Narcan nasal spray.

Pharma executives make a move: recent appointments

29-Jun-2017 - Ocugen welcomes ex-Pfizer Daniel Jorgensen, the IGBMA’s Biosimilars Committee gets a new chair and drug development consultants Boyds hires two associate directors in one go.

Dispatches from Interphex Japan

Pfizer: Global regulatory divergence restricted continuous manufacturing ambition

29-Jun-2017 - Pfizer says a lack of harmony among regulators made its continuous granulation platform untenable for bulk manufacturing but is positive about using such tech for smaller volumes.

BASF to spend €200m to up ibuprofen capacity in Europe and US

28-Jun-2017 - BASF has said it will build an ibuprofen plant in Ludwigshafen, Germany and increase production capacity for the API at a facility in Bishop, Texas in the US.

Mexico legalizes medical marijuana: a boon for pharma?

28-Jun-2017 - Mexican president Pena Nieto has legalised the cultivation, production and use of cannabis products with less than 1% THC for medical uses in Mexico.

Pfizer starts work on Missouri biotherapeutics R&D hub

28-Jun-2017 - Pfizer is building a $200m (€179m) R&D centre in Chesterfield, Missouri at which it will consolidate biotherapeutics process development operations in the region.

Brazil tells Bayer to recall 13 lots of Gynera contraceptive

28-Jun-2017 - Anvisa has ordered Bayer to recall 13 lots of the contraceptive Gynera (gestodene + ethinyl estradiol) over concerns about stability data.

Lonza’s $5.5bn Capsugel takeover cleared by regulators

27-Jun-2017 - Lonza expects to complete its $5.5bn (€5.2bn) takeover of Capsugel SA in the next few days having secured approval from competition authorities around the world.

Open for comment: US FDA confirms backing for continuous manufacturing and calls for industry input

27-Jun-2017 - The US Food and Drug Administration (FDA) has called for drug industry feedback on continuous manufacturing.

Fagron and Advanced Pharma pull drugs made at Pfizer's Rocky Mount site

27-Jun-2017 - Fagron Sterile Services and Advanced Pharma have recalled lots of injectable drugs made at Pfizer’s Rocky Mount facility in North Carolina.

Grace to start making fluorinated drug intermediates with tech from Valliscor

27-Jun-2017 - W.R Grace & Co has announced its intention to start making fluorinated pharmaceutical intermediates with technology obtained from Valliscor Llc.

EMA clears Janssen to make HIV drug using continuous manufacturing approach

26-Jun-2017 - The EMA has cleared Janssen to make the HIV drug Prezista (darunavir) using a continuous manufacturing (CM) process as well as the previously approved batch method.

News in brief

Zynerba starts Ph I study of cannabinoid pain patch

26-Jun-2017 - Zynerba Pharmaceuticals Inc has begun a Phase I trial of cannabinoid patch it is developing for fibromyalgia and peripheral neuropathic pain.

News in brief

Clinical hold for Seattle Genetics’ frontline myeloid leukaemia drug

26-Jun-2017 - The US Food and Drug Administration (FDA) has put Seattle Genetics’ investigational new drug application for vadastuximab talirine (SGN-CD33A) on clinical hold .

US FDA rejects Pfizer's Epogen biosimilar citing McPherson site warning

23-Jun-2017 - Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.

Tetraphase hires Patheon to make its synthetic antibiotic eravacycline

22-Jun-2017 - Tetraphase Pharmaceutical has hired Patheon UK Limited to make and test the synthetic antibiotic eravacycline.

US FDA slams Chinese API maker over data breaches

22-Jun-2017 - Qinhuangdao Zizhu omitted, deleted and manipulated manufacturing data at its active pharmaceutical ingredient plant in Hebei, China according to the US FDA.

Germany’s Merck invests in immune-oncology in Switzerland

21-Jun-2017 - Merck KGaA’s corporate venture division has created an immune-oncology company based on a mixture of small and large molecule drugs, including Merck and Pfizer’s Bavencio (avelumab). 

Corning life science focus: '21st century glass for 21st century drugs'

21-Jun-2017 - Corning says it is on the brink of capturing an increased share of the $12bn glass quality and packaging markets through material advancements in the space.

Patient deaths end Seattle Genetics leukaemia Phase III trial

21-Jun-2017 - Seattle Genetics announced it has discontinued its Phase III Cascade trial of Vadastuximab Talirine (SGN-CD33A) for the treatment of frontline acute myeloid leukaemia (AML), due to patient deaths.

US bans drugs and all but one API made at three IPCA Labs plants

21-Jun-2017 - The US FDA has banned all drugs and all but one of the APIs made by Ipca Laboratories at its facilities in Ratlam, Indore and Piparia.

Implementing continuous manufacturing a challenge, say industry delegates

21-Jun-2017 - Industry professionals at a continuous manufacturing (CM) summit last month said while the approach offers advantages, implementing the method can be challenging.

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