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  • Gilead Sciences, Inc. announced detailed 48-week results from two Phase 3 studies (Studies 1489 and 1490) evaluating the efficacy and safety of a fixed-dose combination of bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing studies, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing dolutegravir (50mg) (DTG) in combination with a dual-NRTI backbone. The data were presented in two late-breaker sessions [MOAB01 and TUPDB02] at the 9th IAS Conference on HIV Science (IAS 2017) in Paris.

  • Cyclacel Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases, announced the closing of an underwritten public offering of units for gross proceeds of USD15.2 million, which includes the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses payable by Cyclacel. Existing and new investors participated in the offering.

    The offering was comprised of Class A Units, priced at a public offering price of USD2.00 per unit, each unit consisting of one share of common stock and a seven-year warrant (each, a “warrant”) to purchase one share of common stock with an exercise price of USD2.00 per share, and Class B Units, priced at a public offering price of USD1,000 per unit, with each unit comprised of one share of preferred stock, which is convertible into 500 shares of common stock, and a warrant to purchase 500 shares of common stock, also with an exercise price of USD2.00 per share. The conversion price of the preferred stock issued in the transaction as well as the exercise price of the warrants are fixed and do not contain any variable pricing features or any price based anti-dilutive features. The preferred stock issued in this transaction includes a beneficial ownership blocker but has no dividend rights (except to the extent that dividends are also paid on the common stock), liquidation preference or other preferences over common stock, and, with certain exceptions, has no voting rights. The securities comprising the units were immediately separable and have been issued separately.

    Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE MKT:LTS), acted as sole book-running manager in connection with the offering.

    A total of 3,154,000 shares of common stock, 8,872 shares of preferred stock convertible into 4,436,000 shares of common stock, and total warrants to purchase 7,590,000 shares of common stock were issued in the offering, including the full exercise of the over-allotment option. If exercised in full, the warrants could result in additional net financing proceeds to Cyclacel of USD15.2 million.


    The securities were offered pursuant to a registration statement on Form S-1 (File No. 333-218305) and an additional registration statement filed pursuant to Rule 462(b), which was declared effective by the United States Securities and Exchange Commission ("SEC").

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A final prospectus relating to this offering has been filed by Cyclacel with the SEC. Copies of the final prospectus may be obtained at the SEC’s website at sec.gov or from Ladenburg Thalmann & Co. Inc., Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172, by calling (212) 409-2000.


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  • Trescon is honouring 50 top performing CIOs and 10 CEOs from the ever-growing Indian Pharmaceutical industry in the upcoming Pharma CIO Conclave & Awards taking place on 9 August 2017 in Mumbai.

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  • The U.S. Food and Drug Administration approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A.

  • Axsome Therapeutics, Inc. a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, enrolled the first patient in the ADVANCE-1 (Addressing Dementia Via Agitation-Centered Evaluation 1) study, a Phase 2/3 trial evaluating the efficacy and safety of AXS-05 for the treatment of Alzheimer’s disease (AD) agitation. AXS-05 is a combination of dextromethorphan (an NMDA receptor antagonist, sigma-1 receptor agonist, and serotonin and norepinephrine reuptake inhibitor) and bupropion (a norepinephrine and dopamine reuptake inhibitor, which also increases the bioavailability of dextromethorphan).

  • Mylan N.V.and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies’ proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin®, which include HER2-positive breast cancer in the metastatic and adjuvant settings.

  • As part of its continued commitment to improving the lives of patients suffering from heart failure and iron deficiency, Vifor Pharma announces three recently-initiated double-blind, placebo-controlled clinical trials, entitled AFFIRM-AHF, FAIR-HF2 and HEART-FID, which will study the effects of Ferinject® (ferric carboxymaltose) versus placebo on morbidity and mortality outcomes.

  • Sanofi announced it will acquire Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut in the United States. Under the terms of the agreement, Sanofi will make an upfront payment of $650 million and pay up to $100 million upon achievement of certain milestones.

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