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Headlines > June 2017

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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.

Anhui Sunhere awarded patent for enzyme-based starch solubilization method

20-Jun-2017 - Anhui Sunhere Pharmaceutical Excipients has been granted a Chinese patent for an enzyme-based method of making starch soluble.

Takeda inaugurates €100m German oral solid dose plant

20-Jun-2017 - Takeda has completed a €100m ($112m) oral solid dosage production facility in Germany.

EMA, FDA and PMDA aim to give antibiotic firms option of global trial programme

20-Jun-2017 - The EMA says aligning antibiotic trial requirements with the US FDA and Japan’s PMDA should allow drug firms to conduct single global development programmes.

Adamis has not set US price for newly approved rival to Mylan's $600 EpiPen

19-Jun-2017 - The US FDA has approved Symjepi, a rival to Mylan’s emergency anaphylaxis treatment EpiPen made by Adamis Pharmaceuticals Corporation.

Pfizer recalls injectables made at Rocky Mount over potential contamination risk

19-Jun-2017 - Pfizer has recalled four injectables – including the already scarce heart surgery drug Sodium Bicarbonate - made at Hospira's facility in Rocky Mount, North Carolina after identifying a potential contamination risk.

News in brief

Nevada law requires insulin firms to disclose prices and profits

19-Jun-2017 - Drug manufacturers selling insulin in Nevada in the US must disclose what they charge and how much the make from the drug under legislation signed into law last week.

A change of focus: B-MS sells Irish API plant to Korean SK Biotek

19-Jun-2017 - Bristol-Myers Squibb (B-MS) has announced it will sell its Swords, Ireland-based API manufacturing facility as part of its focus on biologics.

Update with comment from MHRA

Europe tells API firms UK will be a “third country” like India and China after Brexit

15-Jun-2017 - The European Commission has confirmed that UK drug ingredient manufacturers will have to supply European customers with written confirmation their products are made in compliance with EU standards after Brexit.

US FDA lifts hold on Inovio's cancer vaccine trials after firm answers device questions

15-Jun-2017 - Inovio Pharmaceuticals has started Phase III trials of its DNA-based human papillomavirus therapy VGX-3100 after the US FDA lifted a clinical hold imposed list year.

update

AstraZeneca made Eliquis recalled in US says Bristol Myers-Squibb

15-Jun-2017 - Bristol Myers Squibb (B-MS) says the lot of Eliquis recalled in the US this week was made by AstraZeneca’s contract manufacturing business.

Merck & Co pauses two Ph III Keytruda studies after patient deaths

14-Jun-2017 - Merck & Co has halted two Phase III studies examining its drug Keytruda (pembrolizumab) in combination with other therapies after reports of patient deaths.

Continuous manufacturing: European drug industry eager for EMA guidelines

14-Jun-2017 - European regulators’ efforts to develop continuous manufacturing guidelines are not as advanced as their US counterparts according to delegates who attended a conference last month.

Serialisation tech opens lines of communication

14-Jun-2017 - TraceLink has launched a data platform for pharmacies with EU serialisation requirements, enabling direct communication between drug manufacturers and pharmacies. 

Dr Reddy's says US FDA has closed Miryalaguda plant audit

14-Jun-2017 - Dr Reddy’s Laboratories says it has addressed the problems that earned its API plant in Miryalaguda, Talangana a US FDA Form 483 earlier this year.

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