Industry News

- Read more about CEL-SCI Update Partial Clinical Hold On Phase 3 Clinical Trial
CEL-SCI Corporation announced that company received the Partial Clinical Hold letter from the U.S. Food and Drug Administration (FDA). CEL-SCI has started working on a response to the FDA and will work diligently with the FDA to seek to have the partial clinical hold lifted.
- Read more about Over-dependence on China for key pharma raw material worrying
India may have emerged as a key supplier of generic and affordable medicine for the world market, its overwhelming dependence on China for a crucial raw material , known as Active Pharmaceutical Ingredient (API)to the extent of over 65 percent of the requirement, has emerged as a main worrying area.
- Read more about Sobi's SOBI003 get European Orphan Drug status to treat MPS IIIA
Swedish Orphan Biovitrum AB (publ) (Sobi) has been granted orphan designation by the European Commission (EC) for the company’s development product candidate SOBI003, a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome). SOBI003 will be included in the EU Community Register of Orphan Medicinal Products.

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- Read more about Keystone Nano get US FDA orphan drug status for Ceramides to treat liver cancer
Keystone Nano, a company is working at the interface between nanotechnology and the life sciences, has received orphan drug status for the use of Ceramide to treat liver cancer from the US FDA.
- Read more about FDA accepts for review NDA for sodium zirconium cyclosilicate (ZS-9) for the treatment of hyperkalaemia
AstraZeneca announced that the US Food and Drug Administration (FDA) has accepted a complete re-submission of a New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), a potential new medicine for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. The FDA has indicated that this is a complete class 2 response.
- Read more about FDA Accept Teva’s Resubmitted NDA for SD-809 for Treatment of Chorea Associated with Huntington Disease
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 3, 2017.
- Read more about Lilly's LARTRUVO™ (olaratumab) with Doxorubicin approved by FDA
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted approval of LARTRUVO™ (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. LARTRUVO's indication is approved under Accelerated Approval, and is based on data from the Phase 2 portion of the pivotal JGDG trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Read more about Lannett submit Proposal to FDA Regarding Methylphenidate ER Tablets
Lannett Company, Inc. received a notice from the U.S. Food and Drug Administration (FDA) that it will seek to withdraw approval of the Company's Abbreviated New Drug Application (ANDA) for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) Tablets.
- Read more about BTG submit “first patient in Malaysia receives TheraSphere radioembolisation therapy”
BTG plc, an international specialist healthcare company, announced that the first patient in Malaysia was treated with TheraSphere - a transarterial radioembolisation (TARE) therapy, which targets primary liver cancer and metastatic colorectal cancer with a powerful dose of radiation while minimising exposure to healthy tissue.
- Read more about Generics Expand into GI Markets, Spurring Growth : Reports
The generic versions of various expiring blockbuster drugs are keying growth in the gastrointestinal therapeutics and diagnostic markets. BCC Research reveals in its new report that biologic drugs, in particular, should drive growth in the GI over-the-counter market sector.