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- 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.
- Read more about Lipocine Completes Post Action Meeting With FDA for LPCN 1021 NDA
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.
- Read more about Biotricity Receives a FDA 510(k) Clearance for a key component of its solution
Biotricity inc has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a key component of its solution. This clearance is another watershed moment in the company’s quest to market its remote cardiac monitoring solution comprised of the bioflux software and device. By developing medical remote monitoring solutions that help prevent and manage chronic diseases, biotricity seeks to revolutionize the health industry by bridging the gap in chronic care management.
- Read more about Addex begin phase IIa proof of concept study of dipraglurant in focal cervical dystonia
Addex Therapeutics announced that the company will conduct a phase IIa Proof of Concept Study of dipraglurant in focal cervical dystonia (CD). Addex expects to initiate the trial in the fourth quarter of 2016. The study was developed with support from the Dystonia Medical Research Foundation and in collaboration with investigators from the Dystonia Coalition, an international network of experts devoted to advancing research in dystonia. Buz Jinnah, Director of the Dystonia Coalition and Professor of Neurology at Emory University, will serve as the lead investigator.

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19 October 2016

Pfizer Announces The U.S. Availability Of Biosimilar INFLECTRA

INFLECTRA will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be available in the U.S. It is approved for the treatment of:
-adult patients and pediatric patients (ages six years and older) with moderate to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
-adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy; and
-moderate to severely active rheumatoid arthritis in combination with methotrexate; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis.