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Breaking News on Global Pharmaceutical Technology & Manufacturing

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.

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). 

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.

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.

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.

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.

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. 

Roche accused of charging too much for Herceptin in South Africa

13-Jun-2017 - Roche has been accused of charging too much for its breast cancer drug trastuzumab by South African competition authorities.

Global regulators align to assist antibiotic development in AMR climate

13-Jun-2017 - Regulators in Europe, Japan and the US say they have aligned clinical data requirements for new antibiotics to encourage industry to develop drugs for infections caused by resistant bacteria.

ABPI wants UK minority Government to put pharma at heart of Brexit talks

12-Jun-2017 - Pharmaceuticals should be at the heart of Brexit talks says the Association of the British Pharmaceutical Industry, which has pledged to work with the UK’s minority Government.

News in brief

B-MS recalls US Eliquis Lot after low dose pills found in 5mg bottle

12-Jun-2017 - Bristol Myers Squibb (B-MS) has recalled one lot of the oral anti-clotting drug Eliquis in the US after a customer found 2.5mg strength tablets in a bottle labelled as containing 5mg tablets.

The serialisation deliberation: news and views from NEXUS 17 in Barcelona

08-Jun-2017 - With regulatory deadlines around the corner, the In-PharmaTechnologist team is onsite at TraceLink's first Europe-based NEXUS event, to discuss serialisation, data management and challenges for CDMOs.

China FDA changes will speed up approval process, says CRO

07-Jun-2017 - Proposed changes to drug, medical device and clinical testing regulations provide stimulus for conducting trials in China, says CRO George Clinical.

Moving up in the world: recent pharma appointments

07-Jun-2017 - The US FDA welcomes Scott Gottlieb to the helm, Actinium appoints adult leukaemia expert Richard Stone, and Bill Cheliak bring cannabinoid expertise to Tetra…

Approval for biomarker-based Keytruda a US FDA first

01-Jun-2017 - US FDA has approved a cancer treatment based on a common biomarker, as opposed to the location in the body where the tumour developed.

Valium blister pack tampering leads to Australian recall for Roche and Apotex

01-Jun-2017 - Roche has recalled all batches of Valium 5mg tablets in Australia after finding evidence of product tampering within its supply chain.

Long-acting insulin price concerns challenge WHO proposal

30-May-2017 - Non-profit organisations have challenged the proposed addition of long-acting insulin analogues to the World Health Organisation’s Model List of Essential Medicines, citing price as a key factor.

US ban for Changzhou Jintan Qianyao raises questions about customers says expert

24-May-2017 - The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”

US FDA rejects Sun epilepsy drug due to ongoing problems at Halol plant

24-May-2017 - The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.

EMA proposal concerns: “Public health trumps commercial confidentiality”

23-May-2017 - Proposed amendments to the European Medicines Agency’s (EMA) access to documents policy have been criticised by medicines watchdogs, including not-for-profit Health Action International and Prescrire.

US FDA warns liquid drug firms to test for Burkholderia cepacia

23-May-2017 - Burkholderia cepacia contamination is a risk for drug makers according to the US FDA, which says only rigorous testing can ensure the safety of non-sterile, water-based products.

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