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Pharma news

The latest news from the pharmaceutical industry and suppliers. If you have a piece of news that you would like us to cover, please contact Victoria White on +44 (0)1959 563311 or email us.

Industry News

FDA grants Santhera $246,000 for muscular dystrophy trial

Posted on: 30 August 2016

The FDA have granted Santhera an award of $246,000 in support of its ongoing Phase I trial with omigapil (callisto) incongenital muscular dystrophy (CMD)...

Abeona Therapeutics completes cohort in Sanfilippo syndrome trial

Posted on: 30 August 2016

The first-in-man clinical trial utilises a single injection of AAV gene therapy for patients with MPS IIIA (Sanfilippo syndrome type A), a rare autosomal recessive disease that causes neurocognitive decline, speech loss, loss of mobility, and premature death...

RedHill Biopharma receives patent approval for MS drug

Posted on: 30 August 2016

A first Phase III study with RHB-104 for the treatment of Crohn’s disease is currently ongoing, as well as a Phase IIa proof-of-concept study for the treatment of MS...

Mallinckrodt’s muscular dystrophy drug receives FDA fast track designation

Posted on: 26 August 2016

For the treatment of Duchenne muscular dystrophy (DMD), Synacthen Depot is a synthetic 24 amino acid melanocortin receptor agonist. Outside the US, it...

EMA accepts to review Mylan and Biocon’s cancer biosimilar

Posted on: 25 August 2016

Mylan and Biocon, who co-developed this proposed biosimilar, anticipate that this may be the first MAA for a trastuzumab biosimilar accepted by the EMA...

Intercept’s new PBC liver disease treatment yields successful clinical trials

Posted on: 25 August 2016

The trial evaluated safety and efficacy of ocaliva in PBC patients with an inadequate therapeutic response to, lack of tolerance to, ursodeoxycholic acid...

Novartis’ phase III MS study successfully meets endpoints

Posted on: 25 August 2016

The study included 1,651 people with SPMS randomised to receive either 2mg BAF312 or placebo in a 2:1 ratio respectively, the primary endpoint being an improvement in the time to three-month confirmed disability progression, as measured by the expanded disability status scale (EDSS), versus placebo...

NICE approves CDF drugs for routine NHS use

Posted on: 24 August 2016

The National Institute for Health and Care Excellence (NICE) issued final guidance recommending two drugs for routine use within the NHS: Bosutinib (Bosulif, Pfizer) for treating some patients with leukaemia and Pemetrexed (Alimta, Eli Lilly) for treating some patients with lung cancer...

Pfizer to acquire AstraZeneca’s anti-infective business

Posted on: 24 August 2016

The agreement includes the rights to the newly approved EU drug zavicefta (ceftazidime-avibactam), the marketed agents merrem/meronem (meropenem) and zinforo (ceftaroline fosamil), and the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL...

Janssen submits application to the EMA to expand use of DARZALEX® (daratumumab)

Posted on: 24 August 2016

Phase 3 data supporting submission suggests potential clinical benefit of daratumumab as a backbone therapy in combination with either a proteasome inhibitor (PI) or an immunomodulatory agent for relapsed multiple myeloma patients...

NICE says Bayer’s liver cancer drug is not cost-effective

Posted on: 24 August 2016

NICE originally published guidance in 2010 which said that sorafenib was not cost effective but it was then made available through the CDF. NICE is reconsidering sorafenib as part of its programme to appraise drugs that are currently available...

AstraZeneca and Lilly receive FDA Fast Track designation for AZD3293, an investigational treatment for early Alzheimer’s disease

Posted on: 23 August 2016

AstraZeneca and Eli Lilly and Company have received US FDA Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme inhibitor currently in Phase III clinical trial.


Supplier News

ACG ACPL becomes first Asian company to receive EXCiPACT certification

Posted on: 24 August 2016

ACG Worldwide is pleased to announce that ACG Associated Capsules Pvt. Ltd. (ACG ACPL) has received EXCiPACT certification for its plant at Dahanu – Maharashtra, India.  ACG ACPL is the first empty hard capsule manufacturing company in Asia to receive EXCiPACT certification. The certificate provides independent validation that ACG ACPL maintains excipient Good Manufacturing Practices […]

Yusen Logistics Indonesia acquires highest standard of quality certification for pharmaceuticals transportation

Posted on: 23 August 2016

T Yusen Logistics Indonesia has become the first logistics business in Indonesia to acquire GDP certification...

Yusen Logistics strengthens presence in Mexico with new branch in Guadalajara

Posted on: 10 August 2016

Yusen Logistics is expanding its air freight forwarding network in Mexico with the addition of a branch in Guadalajara...

Microbiological environmental monitoring features in two national conferences supported by Cherwell Laboratories

Posted on: 9 August 2016

Cherwell to offer expert insight in environmental monitoring and process validation to both NHS and industrial pharmaceutical manufacturers...

Joint article on hydrogen peroxide efficacy published in letters in applied microbiology

Posted on: 8 August 2016

Wickham Laboratories Ltd is pleased to announce the publication of a joint study with Bioquell on the efficacy of disinfection by hydrogen peroxide...

New England Biolabs® launches NEBNext Direct™ Technology with Cancer HotSpot Panel

Posted on: 8 August 2016

Novel target enrichment technology, compatible with low input amounts from challenging sample types, uses a one-day workflow...

Lab M launches MMGA pre-poured media plate

Posted on: 29 July 2016

Lab M Ltd, a Neogen company, introduces its Pinnacle™ MMGA (ISO), Mineral Modified Glutamate Agar, pre-poured media plate...

Wickham Laboratories announces new in vitro pyrogenicity testing method

Posted on: 21 July 2016

Wickham Laboratories is pleased to introduce the Monocyte Activation Test (MAT) as the latest addition to its portfolio of in vitro alternatives to in vivo testing methods...

How the implementation of Exalt™ for evaporative crystallisation studies improves stability and controlled delivery in drug development.

Posted on: 12 July 2016

Polymorph screening is an important stage of drug development. The aim is to identify the different crystalline structures or polymorphs that a drug may appropriate...

How & why to build a QbD process to optimise the efficiency of your freeze drying projects

Posted on: 1 July 2016

Quality by design (QbD) for lyophilisation is about building a robust process that proactively flags critical points and ensures consistent delivery of the best quality product, not only by minimising risk but also through greater understanding of the process itself...

Aseptic manufacturing training supported by Cherwell Laboratories

Posted on: 15 June 2016

Cherwell process validation & environmental monitoring product range on display at APDM training course...

Quotient Clinical hosts formulation development and drug delivery seminar series

Posted on: 15 June 2016

Quotient Clinical, the Translational Pharmaceutics® company, is holding a series of formulation development and drug delivery seminars this June and July...



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