Novartis receives FDA warning

June 6, 2013
Manufacturing and Production, Sales and Marketing CGMP, FDA, GMP, Novartis

The FDA has castigated Novartis for what it calls ‘significant violations’ of current good manufacturing practice (CGMP) regulations for finished …

PAN makes series of appointments and promotions

June 6, 2013
Medical Communications Pan, agency, comms

Creative comms agency PAN has bolstered its team with two new arrivals and three promotions. Vanessa Hume has joined the …

Mirna appoints ex-Pfizer senior director

June 6, 2013
Manufacturing and Production, Research and Development, Sales and Marketing Pfizer, miRNA

Biotech firm Mirna Therapeutics has appointed Dr Sinil Kim as vice president of Oncology and chief medical officer. Kim will …

Bayer takes over Conceptus

June 6, 2013
Sales and Marketing Bayer, Conceptus

The Bayer Group, which contains Bayer HealthCare, has taken over US contraception specialist Conceptus in a $1.1 billion deal. The …

Aveo to cut workforce after FDA knock-back

June 6, 2013
Research and Development, Sales and Marketing Aveo, FDA, cuts, tivozanib

Aveo will make major jobs cuts this year after news that a kidney cancer licence for its oncology drug tivozanib …

J&J recalls 32 million contraceptive packs

June 5, 2013
Manufacturing and Production Cilest, J&J, JJ, recall

Johnson & Johnson has announced a 43-country recall of its oral contraceptive Cilest and suspended production of the drug because …

Novartis drug shows cancer promise

June 5, 2013
Research and Development, Sales and Marketing ASCO, Cancer, Novartis

A Novartis drug which has been given breakthrough therapy designation by the FDA has demonstrated early promise in patients with …

Celgene predicts trio of blockbusters

June 5, 2013
Sales and Marketing Celgene, Pomalidomide, Revlamid, Velcade

Europe’s medicines committee the CHMP has just adopted a positive opinion for Celgene’s new multiple myeloma treatment Pomalidomide Celgene (pomalidomide). …

HAVAS LYNX makes several leadership changes

June 5, 2013
Medical Communications, Sales and Marketing Creative Lynx, HAVAS LYNX, PM Society Digital Awards

Comms agency HAVAS LYNX has realigned its senior team making a number of changes for the global firm as it …

GSK licences RA drug

June 5, 2013
Research and Development, Sales and Marketing GSK, RA, morphosys

GlaxoSmithKline is gambling millions of euros on an investigational drug in a bid to get an edge in the fight …

AstraZeneca abandons late-stage RA drug

June 5, 2013
Research and Development, Sales and Marketing AstraZeneca, RA, Rigel

AstraZeneca is to exit development of a new rheumatoid arthritis drug, after Phase III trials produced disappointing results.The Anglo-Swedish firm …

AstraZeneca/BMS drug granted speedy FDA review

June 5, 2013
Sales and Marketing AstraZeneca, BMS, lipodystrophy

AstraZeneca and partner Bristol-Myers Squibb have been granted a priority review for their rare disease drug metreleptin. The medicine is …

Sanofi admits $285m failure

June 4, 2013
Research and Development, Sales and Marketing Sanofi, its benzamide iniparib, otamixaban

Sanofi has consigned two investigational drugs to the corporate dustbin, preferring a $285 million dent in its coffers to continuing …

USP delays guidance on elemental impurities

June 4, 2013
Manufacturing and Production Q3D, USP

The US Pharmacopeial Convention (USP) has agreed to postpone the deadline for implementing two new chapters on elemental impurities in …

NSCLC lift for Boehringer

June 4, 2013
Research and Development, Sales and Marketing Boehringer, NSCLC

Boehringer’s pipeline has been boosted with the news that its investigational oral triple angiokinase inhibitor nintedanib plus chemotherapy, extends the …

Boehringer and Lilly launch diabetes game

June 4, 2013
Medical Communications Boehringer Ingelheim, combat, lilly

Boehringer Ingelheim and Eli Lilly have launched an educational digital game for type 2 diabetes called Complications Combat. The game …

Vocera appoints president and chief executive

June 4, 2013
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Brent Lang, Vocera

Healthcare comms firm Vocera Communications has announced Brent Lang’s appointment as president and chief executive officer to the firm and …

UK government cautious on trial transparency

June 4, 2013
Research and Development, Sales and Marketing Goldacre, UK, alltrials, transparency

Two ministers with responsibility for life sciences in the UK struck a cautious note over clinical trial transparency at an …

SHL attends the 2013 Japan PDA

June 4, 2013
Manufacturing and Production auto injectors, autoinjector, autoinjectors, japan pda. shl pda

SHL once again had the honor of being invited to participate and speak at the PDA Japan 2013 (日本PDA製薬学会), which …

Promising signs for Novartis’ lung cancer drug

June 4, 2013
Sales and Marketing ALK+, ASCO, LDK378, NSCLC, Novartis

Targeted lung cancer treatment LDK378 has been shown to help patients with the ALK+ gene mutation in a phase I trial.Novartis’ drug …

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