ScinoPharm was hurt by weak US demand for the weight loss pill Qsymia, higher raw material prices and costs associated with its still unapproved plant in China in 2014.
Pfizer must act fast to convince investors it can compete with Roche and Biogen Idec for a share of the spinal muscular atrophy (SMA) market says analyst.
The US Food and Drug Administration (FDA) is requesting a budget of $4.9bn for fiscal year (FY) 2016 – a 9% increase over the enacted budget for FY 2015.
Improving investigative site relationships in 2015 is a top priority for pharma and CRO (contract research organization) execs, according to a roundtable recently hosted by the Tufts Center for the Study of Drug Development.
Contract research organization (CRO) Horizon has been selected as a “core facility” for supplying biopharma research tools to academic group the Tri-Institutional Therapeutics Discovery Institute.
Ranbaxy must sell its acne drug minocycline to Torrent Pharmaceuticals and support the firm while it gains regulatory approval for its API supplier before the US Federal Trade Commission will allow Sun Pharmaceutical Industries to complete its $4bn takeover.
Contract development and manufacturing organisation (CDMO) Almac has invested $7m (€5.5m) in a biocatalysis R&D partnership with Queens University Belfast.
The US CDC has recommended that doctors give people Tamiflu (oseltamivir) after detecting that this year's vaccines a less effective than in previous years.
Researchers claiming Tamiflu cuts flu symptom duration and hospitalisations analysed less than half as many studies as were included in the 2014 Cochrane Collaboration review.
Executives’ attitudes are shifting when it comes to supporting the idea that the FDA should evaluate drugs based on both clinical and economic effectiveness, a new PriceWaterhouseCoopers Health Research Institute survey found.
In what was largely a pep rally for science, President Obama on Friday unveiled his $215m precision medicine initiative before a crowd of industry, government and academic scientists and congressmen.
The Association of Clinical Research Organizations (ACRO) is bringing in BioClinica as a regular member and Theorem Clinical Research as an associate member.
While Icon is adding 200 new jobs at a new innovation center in Ireland, PPD is looking to double its packaging warehousing capabilities and quadruple its distribution services on the island.
One quarter after announcing a disappointing book-to-bill ratio, CRO Parexel has now renewed its strategic partnership with GlaxoSmithKline and seen its book-to-bill ratio jump to its highest level since 2012.
Novartis has divested, restructured, or mothballed 24 manufacturing plants since 2010 but says its new NBS cost-saving business will not focus on streamlining and consolidating sites.
AstraZeneca has partnered to use the CRISPR genome editing technique across its discovery programmes in a move that puts it on a collision course with French Biotech, Cellectis.
New hepatitis C drugs produced by Gilead, Janssen and AbbVie contributed to a first quarter spike in revenue for AmeriSourceBergen’s Pharmaceutical Distribution business.
Provectus Biopharmacetuicals is seeking an Indian patent and partner for PV-10 and says it is 'more than a match' for skin cancer competitors like Merck & Co and Bristol-Myers Squibb.
The strengthening US Dollar will reduce CRO revenues, say analysts, but firms which have global strategic deals could benefit from reduced operational costs.
US Pharma firms are prepared for delays in the supply chain caused by Winter Storm Juno thanks to advanced planning and backup generators, says a logistics expert.
A morning sickness drug made by Duchesnay USA will now display Halal and Kosher symbols – a move the company said is the first case of Kosher certification for an oral prescription drug in the US.
Syriza's election victory may prompt drugmakers already burdened with unpaid Greek bills to rethink their presence in the country according to one analyst.
Investment firm William Blair has upgraded preclinical CRO Charles River Laboratories to ‘outperform’ based on strong toxicology demand and the pending acquisition of Covance.
update - GVK is 'respectful' of EMA recommendation and is working with customers
Biotec Services International, daughter company of clinical trial suppliers Packaging Coordinators Inc (PCI), has expanded its cold-chain storage and distribution capacity in response to client demand for a “one-stop shop”.
BASF will spend €56m ($62m) to increase production capacity for the excipient PVP by expanding existing plants and introducing manufacturing capabilities at its facility in Shanghai, China.
ImmuPharma and the recently formed CRO Simbec-Orion Group have entered into a collaboration to run a Phase III clinical study of the potential lupus treatment Lupuzor. Financial terms of the agreement were not released.
Drug industry execs at the World Economic Forum in Davos, Switzerland were told they are no longer best placed to develop antibiotics by a panel who said Governments should lead efforts to create these vital new drugs.
Draft guidance distinguishing wearable medical devices from ‘general wellness’ devices could slow pharma’s adoption of such data in the short-term, according to an analyst.
President Obama in his State of the Union address has called for the power to personally make stronger trade agreements – bringing divisive EU deal TTIP closer to adoption and angering campaigners for drugs access.
Big Pharma firms like AbbVie are partnering with delivery device makers to guard against biosimilar competition according to Unilife CEO, Alan Shortall.
Sydney-based contract research organization Novotech has expanded its Hong Kong operations with a new permanent office and prospects for four more staffers to meet the increasing demand in the research market.
Biopharma outsourcing growth has helped to boost the bottom line of Lonza, the world’s largest manufacturer of drug ingredients, though a topsy-turvy Swiss franc has caused the company to hold off on making any projections for 2015.
The US National Institutes of Health (NIH) has awarded funding to a third organisation performing early-stage clinical trials of infectious disease drugs.
