Latest News in the pharma Industry

Policy & Regulation

OPKO’S Rayaldee product receives FDA approval

OPKO’S Rayaldee product receives FDA approval

22 Jun 2016

First drug to use Catalent’s proprietary OptiShell capsule technology to achieve extended release profile.

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PaizaBio: China approves Drug Marketing Authorization Holder pilot plan

PaizaBio: China approves Drug Marketing Authorization Holder pilot plan

20 Jun 2016

Move approves the use of contract manufacturing organisations.

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Breakthrough combination for patients with skin cancer receives fast-tracked ‘yes’ from NICE

Breakthrough combination for patients with skin cancer receives fast-tracked ‘yes’ from NICE

17 Jun 2016

This represents one of the fastest ever approvals by NICE – UK patients will be the first to benefit across Europe.

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NICE denies NHS patients access to Vertex's Orkambi

NICE denies NHS patients access to Vertex's Orkambi

17 Jun 2016

“As a result of applying the wrong appraisal process, approximately 2,700 people in England who could benefit from Orkambi are being forced to continue waiting for access.”

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Rx-360 summary of the draft WHO HVAC GMPs for non-sterile products

Rx-360 summary of the draft WHO HVAC GMPs for non-sterile products

14 Jun 2016

Document is intended to provide guidance to pharmaceutical manufacturers and inspectors of pharmaceutical manufacturing facilities on the design, installation, qualification and maintenance of the HVAC systems.

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Health Canada approves Inflectra (biosimilar infliximab) for three additional indications

Health Canada approves Inflectra (biosimilar infliximab) for three additional indications

14 Jun 2016

The addition of Crohn's disease, fistulising Crohn's disease and ulcerative colitis to the approved indications was granted on the basis of similarity between Inflectra and the reference product, Remicade.

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Shire receives FDA Breakthrough Therapy Designation for SHP621 and SHP625, investigational products for rare GI conditions

Shire receives FDA Breakthrough Therapy Designation for SHP621 and SHP625, investigational products for rare GI conditions

13 Jun 2016

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FDA approves Vaxchora, PaxVax’s single-dose oral cholera vaccine

FDA approves Vaxchora, PaxVax’s single-dose oral cholera vaccine

12 Jun 2016

Vaxchora is the only approved vaccine in the US for protection against cholera.

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FDA accepts for review Ironwood and Allergan's sNDA for 72 mcg linaclotide in CIC

FDA accepts for review Ironwood and Allergan's sNDA for 72 mcg linaclotide in CIC

9 Jun 2016

The FDA Prescription Drug User Fee Act target action date is expected to occur in early 2017.

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FDA targets unlawful internet sales of illegal prescription medicines during international operation Pangea IX

FDA targets unlawful internet sales of illegal prescription medicines during international operation Pangea IX

9 Jun 2016

FDA has requested the suspension of 4,402 websites and has issued warning letters to the operators of 53 websites illegally offering unapproved and misbranded prescription drug products for sale to US consumers.

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FDA approves once-daily Jentadueto XR Tablets for adults with type 2 diabetes

FDA approves once-daily Jentadueto XR Tablets for adults with type 2 diabetes

31 May 2016

New formulation of medicines that helps lower blood sugar in type 2 diabetes can be taken once a day.

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Flixabi, Biogen’s infliximab biosimilar referencing Remicade, approved in the EU

Flixabi, Biogen’s infliximab biosimilar referencing Remicade, approved in the EU

30 May 2016

Biogen to manufacture and commercialize Flixabi, the company’s second anti-TNF biosimilar therapy in the EU.

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