The EMA has not experienced any concerns with the safety of the 28 biosimilar products it has recommended, according to an information guide published for healthcare professionals.
A head-hunter explains why Regeneron, Novo Nordisk and Genentech top a global survey of science employers, but Pfizer is nowhere to be seen in the top 20.
Capsugel is no longer a simple capsule provider but a differentiated player in the CDMO industry, the firm says as it wins a scale-up manufacturing contract for Chiasma and Roche’s oral octreotide candidate.
The climate for biomanufacturing has changed according to Pfizer, which has set out to win more contracting work for its hormone plant in Sweden and says it will even consider making large molecule drugs for Big Pharma rivals.
Danish biopharma giant, Novo Nordisk is expanding its R&D Centre in China by introducing a new Diabetes Research unit and doubling its quota of employees from 100 to 200 by 2015.
Patients want nasal delivery devices that are portable, hygienic and can be used discretely, according to a director at Valois who delivered a talk on the company’s side-actuated product at CPhI 2009.
Critical Pharmaceuticals has received a £1.5m ($2.4m) award to develop its hGH nasal spray, the market for which could be sizeable as company’s attempt to differentiate in response to generic competition.
Mylan has followed Teva’s lead by partnering to develop follow-on biologics (FOB), with the Indian generic maker regarding Biocon as the “ideal partner” to help it enter the market.
TransPharma Medical has received the European CE mark for its transdermal drug delivery device ViaDerm, which creates pores to allow a therapeutic through the skin.
A surge in research into novel drug delivery systems will occur as companies seek to differentiate their products in response to pressure from biosimilars, according to a publication from Frost & Sullivan.
Modigene says that data from a trial of a Schering-Plough's (SP)
fertility stimulation hormone (FSH-CTP) confirms that carboxyl
terminal peptide (CTP) modification can extend the therapeutic
duration of protein drugs.
The problems facing companies trying to bring 'biosimilar' versions
of biologic drugs to market were thrown into stark relief yesterday
when the US Food and Drug Administration (FDA) refused to approve
Genzyme's genetic...
A disposable autoinjector that incorporates pre-filled syringes to
allow injections to be safely undertaken by patients or
non-clinicians has received FDA approval allowing its creators
access to the lucrative US market.
A new, more patient-friendly presentation of the growth hormone
treatment Omnitrope (rDNA somatropin) has been launched in the US
by Sandoz, the generics division of Swiss-based Novartis.
Israeli generics behemoth Teva is following the market and banking
on the promise of biologics with its purchase of Human Genome
Sciences biotech spin-off, CoGenesys.
Results from a Phase II study of a prolonged release formulation of
octreotide look encouraging for the treatment of acromegaly,
according to Ambrilia Biopharma.
French pharma firm Ipsen has gained marketing authorisation for
Increlex (mecasermin), the first therapy of its kind to be approved
in the EU for long term treatment of severe primary insulin-like
growth factor-1 deficiency (IGFD).
US biopharmaceutical company VGX has strengthened its position in
the plasmid DNA area with the award of two new patents covering the
use and manufacture of plasmid DNA.
In a bid to maintain its position in the human growth hormone (hGH)
market and offer new solutions to patients, Merck-Serono has teamed
up with a US firm to develop a novel growth hormone product that
could offer significant dosing...
Pfizer has entered a capacity expansion phase, to meet requirements
of global manufacturing of Genotropin (somatropin), a top-selling
human growth hormone.
As it looks to the "future of pharmaceuticals," Sandoz is planning
a "powerful biopharmaceuticals programme" with the construction of
a new biopharmaceuticals development centre in Ljubljana, Slovenia.
Biopharmaceutical firm Altus has asked contract manufacturer Althea
to produce Phase III quantities of a crystallised formulation of
human growth hormone (hGH) which can be administered subcutaneously
weekly instead of daily.
Spurred on by the frustration of drug manufacturers, governors from
four US states have petitioned the US Food and Drug Administration
(FDA) for clarity in their requirements for the production of
generic versions of insulin and human...
Aegis Therapeutics has unveiled a new formulation technology
employing non-toxic excipients that maintain the physical stability
and physiological activity of protein and peptide therapeutics
while reducing immunogenicity.
German biopharma firm Sandoz has won a landmark first-of its-kind
biosimilar drug approval in the US after a long battle with the US
Food and Drug Administration (FDA). The decision could open the
floodgates for generics manufacturers...
Swiss biopharmaceutical firm Biopartners has got the thumbs up from
the European Commission for its biosimilar drug Valtropin, making
it only the second biogeneric drug to have been approved in Europe
after Sandoz's Omnitrope...
Dragon Pharmaceutical has bowed out of a development and
manufacturing contract with Austria's Polymun Scientific, selling
it instead to Swiss company AS Biotech for $1m.
The firing of Dr Peter Rost by Pfizer highlights the position that
employees can be faced with if they take a stand on what they
believe to be illegal activity in the companies they work for.
Regulatory obstacles to the development of the market for
biogeneric drugs are falling down, and the first products are set
to reach the markets of North America and Europe in 2006-7,
according to consulting firm Frost & Sullivan.
US firm Bolder BioTechnology has been awarded a patent for a new
technology that allows therapeutic proteins to be modified
chemically to improve its activity in the body.
Novartis has paid a US drug delivery company $10 million for an
option to an oral formulation of an injectable drug used to treat
osteoporosis that is currently the subject of litigation with Eli
Lilly.
Switzerland-based BioPartners has submitted a second Marketing
Authorisation Application in Europe for a generic copy of a
biologic drug under the recently agreed European Union framework
for so-called 'biosimilar' drugs.
Danish pharmaceutical firm Novo Nordisk has announced plans for a
significant expansion of its production facilities in China,
expanding its capabilities to accommodate the increasing demand for
its FlexPen, NovoPen and Penfill products.
Swiss biopharmaceuticals company BioPartners has filed its first
application in Europe for a generic version of interferon alpha, a
biological drug. If approved, the 'biosimilar' could be on the
market as early as next year.
Danish pharmaceutical firm Novo Nordisk has launched a new product
in its Norditropin range of human growth hormone (hGH) that
simplifies the delivery of the drug to children with growing
difficulties.
