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In efforts to develop new treatments for brain cancer, scientists from Johns Hopkins Drug Discovery and the Kimmel Cancer Center's Bloomberg~Kimmel Institute for Cancer Immunotherapy report they have altered the structure of an experimental drug that seems to enhance its ability to slip through the mostly impermeable blood-brain barrier.
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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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.
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.
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.
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.
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.
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.
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.
Lipocine Inc. announced the completion of a Post Action meeting with the U.S. Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The purpose of the meeting was to review the Complete Response Letter ("CRL") and to determine actions needed to achieve approval of LPCN 1021.
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