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US breakthrough status for InterMune’s pirfenidone

US breakthrough status for InterMune’s pirfenidone

21-07-2014

US biotech firm InterMune’s Esbriet (pirfenidone) has been granted Breakthrough Therapy designation…

BiotechnologyEsbrietFood and Drug AdministrationInterMunepirfenidoneRare diseasesRegulationRespiratory and PulmonaryUSA

Pharming and Salix gain US approval for Ruconest

Pharming and Salix gain US approval for Ruconest

17-07-2014

Netherlands-based Pharming Group and Salix Pharmaceuticals have received approval from the US Food and…

BiotechnologyPharmingRare diseasesRegulationRuconestSalix PharmaceuticalsUSA

Canada approves Pendopharm’s all-oral ribavirin treatment Ibavyr for hepatitis C

Canada approves Pendopharm’s all-oral ribavirin treatment Ibavyr for hepatitis C

16-07-2014

Quebec-based Pendopharm, a division of privately-held Canadian drugmaker Pharmascience, says the regulator…

Anti-viralsBiotechnologyCanadaIbavyrPendopharmPharmascienceRegulation

NICE issues positive draft FAD guidance on Tecfidera

NICE issues positive draft FAD guidance on Tecfidera

11-07-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued…

Biogen IdecBiotechnologyMultiple sclerosisNeurologicalPricingRegulationTecfideraUK

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

11-07-2014

US RNA-based drug developer Sarepta Therapeutics saw its shares plunge, despite the company releasing…

BiotechnologyeteplirsenRare diseasesRegulationResearchSarepta TherapeuticsUSA

Beike receives approval from Chinese FDA for umbilical stem cells in lupus

Beike receives approval from Chinese FDA for umbilical stem cells in lupus

10-07-2014

China-based stem cell research company Beike Biotechnology has been accepted into the approval process…

beikeBeike BiotechnologyBiotechnologyChinaGuangdong Food and Drug AdministrationImmunologicalsRegulationStem cells

Regado Biosciences announces FDA’s clinical hold of Ph III trial

Regado Biosciences announces FDA’s clinical hold of Ph III trial

10-07-2014

The US Food and Drug Administration (FDA) has informed US-based cardiovascular specialist Regado Biosciences…

Acute coronary syndromeBiotechnologybivalirudinCardio-vascularMedicineRegadoRegulationUSA

FDA approval for Protein Sciences’ 2014/15 formulation of Flublok

FDA approval for Protein Sciences’ 2014/15 formulation of Flublok

09-07-2014

The US Food and Drug Administration has approved privately-held US biotech firm Protein Sciences’ strain…

BiotechnologyFlublokInfluenzaProtein Sciences CorpRegulationUSAVaccines

$25 million milestone for Incyte on Japanese approval of Jakavi

$25 million milestone for Incyte on Japanese approval of Jakavi

08-07-2014

US biopharma company Incyte says it has earned a $25 million milestone payment from Swiss drug major…

BiotechnologyBusiness FinanceBusiness FinanceFinancialIncyteJakaviJapanMajorMedicineNovartisOncologyRegulationRuxolitinib

Australia’s TGA clears the way for Gilead’s Sovaldi for hepatitis C

Australia’s TGA clears the way for Gilead’s Sovaldi for hepatitis C

08-07-2014

Australian health care regulator the Therapeutic Goods Administration (TGA) has approved the use of US…

Anti-viralsAustraliaBiotechnologyGilead SciencesRegulationSovaldi

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

USA’s GPhA and numerous other groups lodge concerns on biosimilars names

02-07-2014

A total of 32 organizations have signed a letter calling on the US Food and Drug Administration to require…

BiosimilarsBiotechnologyRegulationUSA

Breakthrough status for Amgen’s blinatumomab in ALL

01-07-2014

USA-based Amgen, the world's largest independent biotech firm, says that the US Food and Drug Administration…

AmgenBiotechnologyblinatumomabOncologyRegulationUSA

Gilead submits for approval of hepatitis C drug Sovaldi in Japan

Gilead submits for approval of hepatitis C drug Sovaldi in Japan

27-06-2014

US biotech firm Gilead Sciences revealed this morning it has submitted a New Drug Application to Japan's…

Anti-viralsBiotechnologyGilead SciencesJapanRegulationSovaldi

Vertex leaps on positive Ph III results with lumacaftor

Vertex leaps on positive Ph III results with lumacaftor

24-06-2014

US biotech firm Vertex Pharmaceuticals saw its share price rocket nearly 52% to $101.20 in extending…

BiotechnologyBusiness FinanceCystic fibrosisHealth Medical PharmaKalydecolumacaftorMedicinePhenolsRare diseasesRegulationResearchVertex Pharmaceuticals

Alnylam and TAP collaborate on ALN-AAT, for AAT deficiency-associated liver disease

Alnylam and TAP collaborate on ALN-AAT, for AAT deficiency-associated liver disease

19-06-2014

RNAi therapeutics company Alnylam Pharmaceuticals and The Alpha-1 Project (TAP), the venture philanthropy…

ALN-AATAlnylam PharmaceuticalsBiotechnologyNephrology and HepatologyRegulationResearchThe Alpha-1 ProjectUSA

US orphan status for Mirati’s mocetinostat and Alexion’s Soliris

US orphan status for Mirati’s mocetinostat and Alexion’s Soliris

17-06-2014

USA-based Mirati Therapeutics has been granted Orphan Drug designation by the US Food and Drug Administration…

BiotechnologyOncologyRare diseasesRegulation

Celgene exercises option for Agios Pharma’s AG-221

Celgene exercises option for Agios Pharma’s AG-221

17-06-2014

Metabolism specialist Agios Pharmaceuticals says that its partner, biotech major Celgene Corp, has exercised…

AG-221Agios PharmaceuticalsBiotechnologyCelgeneLicensingOncologyRegulationResearchUSA

Novartis files for US approval of meningitis B vaccine Bexsero

Novartis files for US approval of meningitis B vaccine Bexsero

17-06-2014

Swiss pharma major Novartis has submitted a Biologic License Application to the US Food and Drug Administration…

BexseroBiotechnologyNovartisRegulationUSAVaccines

Gilead’s ledipasvir/sofosbuvir achieved 100% SVR12 among chronic hepatitis C patients in Japan

Gilead’s ledipasvir/sofosbuvir achieved 100% SVR12 among chronic hepatitis C patients in Japan

16-06-2014

US anti-virals major Gilead Sciences has released strong top-line results from a Phase III clinical trial…

Anti-viralsBiotechnologyGilead SciencesJapanledipasvirRegulationResearchsofosbuvirSovaldi

UK NICE consults on draft guidance for Gilead’s hepatitis C drug Sovaldi

UK NICE consults on draft guidance for Gilead’s hepatitis C drug Sovaldi

16-06-2014

In draft recommendations published today, UK health care watchdog the National Institute for Health and…

Anti-viralsBiotechnologyGilead SciencesPricingRegulationSovaldiUK

Takeda to withdraw NDA as Omontys pact with Affymax ends

Takeda to withdraw NDA as Omontys pact with Affymax ends

15-06-2014

USA-based Affymax and Japan's Takeda Pharmaceutical revealed on Friday that they have terminated their…

AffymaxBiotechnologyLicensingOmontysOncologyRegulationTakeda Pharmaceutical

Geron leaps as FDA lifts partial hold on imetelstat trial

Geron leaps as FDA lifts partial hold on imetelstat trial

13-06-2014

US biotech Geron Corp's shares jumped around 27% to $3.31 in early afternoon trading yesterday after…

BiotechnologyGeron CorpHematologyimetelstatOncologyRegulationUSA

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