CDMO (contract development and manufacturing organization) Xcelience has made a structured cash investment in Pennsylvania-based Powdersize, which specializes in milling, micronization and powder size classification.
CRO Quintiles on Friday announced the pricing of a secondary public offering of 7,000,000 shares of its common stock at a price to the public of $77.85 per share, which is about $1 more per share than what the stock was selling for on Friday.
As the US regulator awards iclaprim expedited QIDP status, a former FDA antibiotics expert says the scheme boosts antibiotics without enough evidence for efficacy.
Beginning Sept. 30, Massachusetts-based CRO (contract research organization) Parexel will lay off as many as 125 of the 450 employees it brought on from GlaxoSmithKline (GSK) in North Carolina late last year, according to a North Carolina WARN report...
"People are the essence of the company going forward," said Teva, referring to the news that the world's largest generic drug maker will purchase Allergan's generics business for $40.5bn, at its Q2 financial results press conference...
Contract research organization Charles River Laboratories has extended its initial three-year strategic partnership with AstraZeneca for an additional five years.
Contract research organization INC Research reported 14.2% net service revenue growth in Q2, compared to the same quarter last year, raised future guidance and saw its stock bump up more than 10%.
Industry headhunters have picked their top CEOs in European pharma, saying the most successful investors keep chief execs in place even through hard times.
A drug delivery platform which increased the bioavailability of a cannabis-based drug candidate 30% could be used to boost solubility of other APIs, says Echo Pharmaceuticals.
The €3m Afrezza has contributed to Sanofi’s revenues since launch is unlikely to subdue growing concerns from commentators surrounding its partner MannKind which developed the inhalable insulin.
Consistent Q2 growth for the world’s largest CRO (contract research organization) Quintiles was driven by a spike in the company’s Integrated Healthcare Services (IHS) segment.
LabCorp revealed a more than 46% increase in quarterly revenue from the same quarter last year as the recent $6.2bn acquisition of Covance brought in $620.8m of the overall company’s $2.2bn in Q2.
A shipment of drugs stolen while a truck driver went home to change his clothes were recovered in half an hour thanks to a GPS tracking device embedded in the cargo.
A five-month legal battle over the duties of trial sponsors to publish results has ended with a judge ruling the UK regulator acted unlawfully and sponsors will not be required to publicly register UK Phase I adult trials which began before September...
CRO (contract research organization) Icon reported its highest level of quarterly bookings ever on Tuesday and the company’s stock jumped by about 15%.
CRO (contract research organization) PRA Health Sciences reported in its earnings call on Tuesday that earlier in Q2 it acquired Value Health Solutions (VHS), a clinical development software company, for $2.5m.
New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.
Pharma firms may need to carry-out an analytical method comparability study as part of the life cycle management of a drug, according to final US FDA guidelines.
A surge of demand in biologics contract testing and biosimilar characterization has caused BioOutsource to double its capacity with the opening of a new facility in Glasgow, Scotland.
As the number of approved clinical trials in India continues to taper off compared to years past, a government task force is now calling for a new expedited trial approval process.
A Standards & Poor analyst has rated contract development and manufacturer AMRI as ‘stable,’ but says it lacks the scale and breadth of offerings of its competitors in the CDMO industry.
DNA sequencing firm Source BioScience will bolster its stability testing and storage services through a proposed acquisition of Select Pharma Laboratories.
A confidential information exchange agreement will strengthen the relationship between the EMA and Swiss regulators and could save on resources, the agencies say.
IPEC Europe has reminded drugmakers they have less than a year to risk assess all excipients used in their products under recently introduced EU rules.
Roche is expanding its manufacturing operations to service its biologics pipeline, but the firm says it will continue to outsource approximately 20% of all production.
Capsugel is doubling the size of a facility in Scotland to support demand for the encapsulating of drugs containing high-potency active pharmaceutical ingredients (HPAPIs).
Increasing pharma R&D spending is helping grow revenues for Medidata, which has boosted its cloud-based clinical technology through a partnership with Validic.
Investor backing puts transparency on the pharma agenda says SenseAboutScience, even though none of the funds pledging support for Alltrials have committed to pull investment from drug firms that disagree.
Companies that recommission old single-use devices would have the same liability as the original device maker under draft guidelines proposed by the MHRA.
Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.
Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.
EAG (Evans Analytical Group), an independent laboratory network, has acquired Missouri-based Analytical Bio-Chemistry Laboratories (ABC Labs). Financial terms of the transaction were not disclosed.
As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory review process that could relieve some of the uncertainty around the use of new excipients.
Ethiopia will start making its own APIs in 2020 according to the Government which says local manufacture will improve access to medicines, curb sale of counterfeits and promote innovation.
Demand for West’s wearable injector - which uses the recently-approved Crystal Zenith delivery system - has led to the expansion of a facility in Arizona.
