Latest News in the pharma Industry

Policy & Regulation

Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the EMA

Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the EMA

31 May 2017

Biosimilar infliximab alone could potentially save the NHS £89 million.

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Lupin Pharmaceuticals announces nationwide recall of Mibelas 24 Fe tablets

Lupin Pharmaceuticals announces nationwide recall of Mibelas 24 Fe tablets

30 May 2017

Recall due to out of sequence tablets and missing expiry/lot information.

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FDA accepts for priority review BMS’s application for Opdivo in previously treated hepatocellular carcinoma

FDA accepts for priority review BMS’s application for Opdivo in previously treated hepatocellular carcinoma

26 May 2017

Application is based on results from the Phase I/II CheckMate -040 trial.

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WuXi STA, CFDA and Jinshan Government to co-host Marketing Authorization Holder regulatory summit in Shanghai

WuXi STA, CFDA and Jinshan Government to co-host Marketing Authorization Holder regulatory summit in Shanghai

25 May 2017

Industry and regulators combine to run afternoon congress on the implications of regulatory changes.

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FDA approves Kevzara for the treatment of moderately to severely active RA in adults

FDA approves Kevzara for the treatment of moderately to severely active RA in adults

23 May 2017

Kevzara is now available to US patients.

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FDA approves Genentech’s Actemra for giant cell arteritis

FDA approves Genentech’s Actemra for giant cell arteritis

22 May 2017

Sixth FDA approval for Actemra since its US launch in 2010,

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EMA validates application for BMS’s Sprycel in children with chronic myelogenous leukemia

EMA validates application for BMS’s Sprycel in children with chronic myelogenous leukemia

20 May 2017

Proposal extends application to the treatment of children and adolescents with chronic phase Philadelphia-chromosome positive chronic myelogenous leukemia and to the powder for oral suspension.

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Saneca Pharma receives confirmation of multi-dosage cGMP approval for Russia

Saneca Pharma receives confirmation of multi-dosage cGMP approval for Russia

17 May 2017

Certification covers the manufacture and packaging of hard and soft gel capsules, liquids for external use, semi-solids such as ointments and film coated tablets.

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Aptar Pharma’s electronic Lockout device approved by EMA

Aptar Pharma’s electronic Lockout device approved by EMA

16 May 2017

The e-Lockout device being the first and only fully integrated electronic nasal drug delivery device to be approved by a US or European regulatory authority.

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Research reveals manufacturers and contract packagers may miss serialization deadlines

Research reveals manufacturers and contract packagers may miss serialization deadlines

15 May 2017

Many companies currently unprepared because they lack the internal resources to devote to serialization.

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Hikma receives CRL regarding its ANDA for generic Advair Diskus

Hikma receives CRL regarding its ANDA for generic Advair Diskus

11 May 2017

Company believes low likelihood of approval this year.

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Merck's Keytruda scores another FDA approval

Merck's Keytruda scores another FDA approval

11 May 2017

FDA approves Keytruda as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression.

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