All news

NDMA investigation leads to cases discovered in diabetes treatment

09-Dec-2019 By Ben Hargreaves

After NDMA contamination is found by Singaporean authorities, both the FDA and EMA state they are working on the testing of metformin treatments.

Mylan aims to address FDA warning letter in next 6 months

09-Dec-2019 By Nick Taylor

Mylan sets sights on addressing US FDA warning letter in the ‘next quarter or a couple of quarters.’

Almac granted $1m to develop low-cost API manufacturing method

09-Dec-2019 By Vassia Barba

Under funding from Bill and Melinda Gates Foundation, Almac initiates work to develop biosynthetic routes for APIs to be used in world aid programs.

LEO partners for needle-free delivery of biologics

05-Dec-2019 By Ben Hargreaves

LEO and Portal collaborate in the development of needle-free device to allow patient to self-administer dermatology products.

Kyowa Kirin creates quality unit with direct line to CEO

05-Dec-2019 By Nick Taylor

Kyowa Kirin reorganizes to create quality division that reports directly to CEO Masashi Miyamoto.

Novartis chooses Amazon cloud services to rebuild network

05-Dec-2019 By Vassia Barba

Novartis adopts enterprise-wide data and analytics services from Amazon, under a multi-year agreement.

Pharma Integrates

Addressing talent: AI and advanced therapies the most competitive areas

04-Dec-2019 By Vassia Barba

Representatives from companies providing recruitment services to the pharmaceutical industry discuss the challenges on ‘winning the talent war’ during Pharma Integrates.

CureVac gets approval to scale up mRNA production

03-Dec-2019 By Ben Hargreaves

CureVac receives EMA approval for its GMP III production suite, which will be able to provide clinical trial materials and commercial supply of mRNA.

Horizon opens West Coast manufacturing site to tap talent pool

03-Dec-2019 By Nick Taylor

Horizon Therapeutics opens South San Francisco, US, manufacturing and R&D site to tap into talent pool in biotech hotspot.

FDA approves first drug to target the root cause of sickle cell disease

02-Dec-2019 By Vassia Barba

Global Blood Therapeutics receives approval for Oxbryta, making it the first approved drug product that targets the root cause of sickle cell disease.

Icon braces for BMS-Celgene merger to slow RFP activity

02-Dec-2019 By Nick Taylor

Icon prepares for slowdown in request for proposal (RFP) activity, as BMS and Celgene merge.

Boehringer Ingelheim taps NiceLabel to improve label management

02-Dec-2019 By Vassia Barba

Boehringer Ingelheim adopts a label management system developed by NiceLabel, replacing manual quality control procedures with digital technology.

Asahi Kasei in $1.3bn bid to access US pharma market

28-Nov-2019 By Ben Hargreaves

Asahi Kasei has a bid accepted for oral dose specialist, Veloxis, with one eye on gaining a position in the US market.

Celltrion gets EMA nod for subcutaneous infliximab biosimilar

28-Nov-2019 By Vassia Barba

Celltrion receives EMA marketing authorisation for Remsima SC, the first subcutaneously-administered option for delivery of infliximab, a treatment for rheumatoid arthritis.

Recro spins out Baudax to boost CDMO focus

28-Nov-2019 By Vassia Barba

Recro Pharma announces the separation of its acute care business to launch Baudax Bio as a developer of products, including non-opioid analgesics, to concentrate on its CDMO business.