Generics Industry News Search
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March 2009 News Archive |
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Aurobindo Pharma Limited is pleased to announce that its wholly owned subsidiary Aurobindo Pharma Australia Pty Ltd has received it's first approval from Therapeutic Goods Administration (TGA), Government of Australia for the registration of Auro-Lisinopril 5, Auro-Lisinopril 10 and Auro-Lisinopril 20 tablets containing Lisinopril (as dihydrate) 5mg, 10mg and 20mg.
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KV Pharmaceutical Company today announced that it has entered into a consent decree with the U.S. Food and Drug Administration (FDA) regarding the company's drug manufacturing and distribution. The decree provides a series of measures that, when satisfied, will permit KV to resume the manufacture and distribution of products marketed by its subsidiaries, ETHEX and Ther-Rx. The Company is working expeditiously to satisfy the requirements and expects to provide further information in upcoming communications....
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Looks like Pfizer isn't content to sit and wait for the revenue boost that Wyeth will provide once Pfizer swallows it up: The giant drugmaker announced two partnerships to boost the top line today....
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Aurobindo Pharma is pleased to announce that it has expanded its partnership further by executing licensing and Supply agreements for several Solid Dosage and Sterile products with Pfizer Inc., a global leader in Pharmaceuticals. ...
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Actavis Group hf, the Icelandic drugmaker that's up for sale, may consider selling itself in pieces to attract more offers, according to two people familiar with the matter...
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Synthon announced today that it has successfully concluded its registration procedures for Levocetirizine. Regulatory clearance has been obtained for Synthon's product in fourteen European countries using decentralized procedures...
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Teva Health Systems is pleased to announce the introduction and availability of Amiodarone Hydrochloride Injection in a new 18 mL vial size...
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In January, leading pharmaceutical experts attended the 2009 Forum Institute seminar on biosimilars, and the challenges involved in their successful development and launch. While the main focus of the meeting the biosimilars market in the EU, it was widely agreed that developments in the US, and President Obama's handling of the generic biotech issue, will be the defining issue of 2009 and beyond...
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Ranbaxy Laboratories Limited, announced today that the company has received an approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Quinapril Hydrochloride & Hydrochlorothiazide Tablets, 10mg/12.5mg, 20mg/12.5mg and 20mg/25mg...
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Lawyers at AstraZeneca will begin the long process of defending the company's all-important cholesterol drug Crestor from generic competition in a U.S. courtroom next week...
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Indian drugmakers aren't deterred by the FDA's crackdown on India's largest generics maker, Ranbaxy. And they have good reason not to be...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that it has reached a settlement with Elan Corporation, Plc on outstanding patent litigation related to Watson's generic version of Naprelan (naproxen sodium) tablets...
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Ranbaxy Laboratories Limited announced today that the Company has received an approval from the Therapeutic Goods Administration (TGA), Department of Health and Ageing, of the Australian Government, for the registration of Sebifin Terbinafine Tablets in Australia...
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Sun Pharmaceutical Industries Ltd. today announced its subsidiary, Alkaloida Chemical Company Exclusive Group Ltd. (Alkaloida), has extended the Expiration Date of the Tender Offer for the purchase of all outstanding Ordinary Shares of Taro New York City time, on Friday, March 20, 2009, unless further extended or earlier terminated. The Tender Offer was extended to comply with a continuing order issued by the Supreme Court of Israel temporarily prohibiting the closing of the Offer until the Supreme Court issues a decision on the appeal of the litigation commenced against Alkaloida and its affiliates by Taro and certain of its directors regarding the applicability of the special tender offer rules under the Israeli Companies Law to the Offer. The Tel-Aviv District Court had previously ruled in favor of Sun that a special tender offer was not required....
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Genzyme Corp., the world's largest maker of drugs for rare genetic disorders, sued Indian drug maker Lupin Ltd. for allegedly infringing four US patents for kidney medicine Renagel...
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Aurobindo Pharma Limited is pleased to announce that it has received tentative approval for Escitalopram Oxalate Tablets 5mg, 10mg and 20mg from the US Food & Drug Administration (USFDA).
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Actavis has launched the oncology product Gemcitabine in EU markets, at patent expiry. The launch represents a significant milestone in Actavis' developing hospital business....
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Ranbaxy Laboratories Limited, announced today, that the Company has received an approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), to market and manufacture Ramipril Capsules 5mg & 10mg. The application for the drug was submitted by Ranbaxy from the Ohm Laboratories manufacturing facility, located in North Brunswick, New Jersey, USA. The Office of Generic Drugs, USFDA, had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug, Altace by King Pharmaceuticals Inc. ...
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Article One Partners LLC has discovered new prior art impacting the validity of Merck & Co.'s Singulair U.S. drug patent. A request is being filed today with the U.S. Patent Office to review the patent in a reexamination proceeding. An independent law firm and an independent expert join Article One's opinion that a substantial new question of patent validity is raised by the success of Article One's research and should be reviewed by the Patent Office...
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Drug developer Eli Lilly & Co. said Monday a U.S. district court granted its request to temporarily halt generic drug maker Teva Pharmaceutical Industries Ltd. from launching a version of the osteoporosis drug Evista....
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Clamelle was once again the talk of the town at the OTC Marketing Awards 2009 in London on the 5th March, winning two of the prestigious awards....
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Sepracor Inc. today announced that it has entered into a Settlement and License Agreement with Teva Pharmaceuticals USA, Inc. (Teva) and Barr Laboratories, Inc. (Barr), a wholly owned subsidiary of Teva, to resolve the patent litigation against Barr involving Sepracor's Xopenx brand levalbuterol HCl Inhalation Solution products (1.25 mg/3 mL, 0.63 mg/3 mL and 0.31 mg/3 mL) and to grant a license to Barr and Teva...
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A federal judge has dismissed AstraZeneca AB's patent lawsuit against Dr. Reddy's Laboratories Ltd. over the generic formulation of popular over-the-counter antacid medication Prilosec...
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Prasco Laboratories, announced today it has entered into a marketing and distribution agreement with GlaxoSmithKline. Flonase (fluticasone propionate) Nasal Spray is the first product to be marketed under this agreement...
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With an EU regulatory framework in place to address the safety of biosimilars - also known as follow-on biologics - the opportunity represented by these products has been proven, and it is growing. Japan and the US are both following suit and exploring legislative development....
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U.S. lawmakers unveiled a bipartisan proposal on Wednesday to allow government approval for cheaper copies of biotechnology medicines that cost as much as tens of thousands of dollars per year...
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Strides Arcolab Ltd has announced with reference to the 'License and Supply Agreement' signed by Strides Arcolab Ltd with KV Pharmaceutical Company, USA (KV) in the year 2005, pursuant to which Strides had agreed to develop certain products to be exclusively licensed to KV and also manufacture and supply such products to KV for sale in certain territories....
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Dr. Reddy's Laboratories today announced that the U.S. District Court (Southern District, New York) has granted a summary judgment that the Omeprazole Mg OTC ANDA filed by Dr. Reddy's does not infringe the patents in suit related to Astra Zeneca’s Prilosec OTC...
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Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, has received the first and only tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Lopinavir/Ritonavir Tablets, 200 mg/50 mg...
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Pronova BioPharma ASA today announces that it and its U.S. marketing partner GlaxoSmithKline Inc. have received a Paragraph IV Notice Letter dated March 9 2009 from Teva Pharmaceuticals USA, Inc. (Teva) advising that Teva has submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for approval to market a generic version of Lovaza...
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Following the signature of a preliminary agreement last November, Actavis Group and ASKA Pharmaceutical have now formally signed an agreement establishing a joint company: Actavis ASKA K.K...
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Natco Pharma Ltd today announced that it has successfully opposed a patent application in India that covers the composition of Glatiramer Acetate, the generic version of Teva's Copaxone. The patent application was submitted to the Indian Patent Office (New Dehli) by Yeda Research & Development Company, which licensed the Glatiramer Acetate product to Teva...
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Shire plc announces that it has filed a lawsuit in the U.S. District Court of the Southern District of New York against Barr Laboratories, Inc. for infringement of three of Shire's patents: U.S. Patent No. 5,968,976;U.S. Patent No. 7,381,428; and U.S. Patent No. 7,465,465...
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RoundTable Healthcare Partners, an operating-oriented private equity firm focused exclusively on the healthcare industry, announced today that its portfolio company CorePharma LLC has completed the acquisition of an ANDA for Leucovorin Calcium tablets...
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Perrigo Company today announced that its partner Cobrek Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) for Clindamycin Phosphate Foam 1%, a generic version of Evoclin Foam 1%. The Company believes that Cobrek is the first to file an ANDA with a Paragraph IV certification against Evoclin...
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Abbott Laboratories accused rival Mylan Inc. of infringing two U.S. patents for the AIDS drug Kaletra...
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Genzyme Corporation in connection with its Renagel (sevelamer hydrochloride) tablets, 400 mg and 800 mg...
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Impax Laboratories, Inc. today confirms that it has provided notice to the patent and New Drug Application (NDA) holders that it has submitted an Abbreviated New Drug Application (ANDA) for Doxycyline hyclate delayed-release tablets 150 mg, generic of Doryx, to the U.S. Food and Drug Administration (FDA). Impax's ANDA, contains a Paragraph IV certification stating that the Company believes its product does not infringe US Patent No. 6,958,161, or that the patent is invalid or unenforceable...
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On March 16, 2009, the Food and Drug Administration granted tentative approval to a generic formulation of Lamivudine tablets, 150 mg, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. The drug is manufactured by Alkem Labs Ltd., of Mumbai, India.
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Medicis Pharmaceutical Corporation's acne treatment Solodyn (Minocycline HCl) Extended-Release Tablets, 45 mg, 90 mg and 135 mg. Shipment of this product has commenced....
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Strides Arcolab is pleased to announce that the USFDA, post a GMP & pre-approval inspection approved the Company's Sterile Complex at Bilekahalli, Bangalore to be cGMP compliant.
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Medicis and Teva Pharmaceutical Industries Ltd. (Teva) today announced they have agreed to terminate all legal disputes between them relating to Solodyn (minocycline HCl, USP) Extended Release Tablets. Pursuant to an agreement entered into between the parties, Teva has confirmed that Medicis' patents relating to Solodyn are valid and enforceable, and cover Teva's activities relating to its generic product under Abbreviated New Drug Application ...
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Dr. Reddy's Laboratories announced that it has realigned its Global Generics finished dosages strategy to focus on certain key geographies and would gradually exit some of the very small distributor driven markets. The markets being exited would have an overall contribution of less than 1% to the topline. In addition to the US, India, Russia & CIS and Germany where the operations are already very large contributing to approx 90% (fig. for 9 months ended Dec 2008) of the Global Generics revenues, the company will continue operations in 10-15 markets wherein the company's finished dosages sales are growing significantly....
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Impax Laboratories, Inc. today announced that beginning July 1, 2009, Impax Pharmaceuticals, the Company's specialty brand products division will co-promote Wyeth's Pristiq. Impax Pharmaceuticals will utilise its 66 neurology-focused sales force to promote Pristiq (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor (SNRI) as a treatment for adult patients with major depressive disorder (MDD). ...
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Warner Chilcott Limited announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd. (Mayne) have filed a second lawsuit against Impax Laboratories, Inc. in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 which covers Doryx, a tetracycline-class oral antibiotic...
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OSI Pharmaceuticals, Inc. announced today that the Company has filed two lawsuits in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. and Mylan Pharmaceuticals, Inc. for infringement of US Patent No. 5,747,498, US Patent No. 6,900,221 and US Patent No. 7,087,613. All three patents are associated with Tarceva (Erlotinib). ...
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Shire plc announces that it has filed a lawsuit in the U.S. District Court of the Southern District of New York against Mylan Inc., Mylan Pharmaceuticals Inc. and Matrix Laboratories Limited for infringement of Shire's patent: U.S. Patent No. 5,968,976 ...
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Sun Pharmaceutical Industries Ltd. today announced its subsidiary, Alkaloida Chemical Company Exclusive Group Ltd., has extended the Expiration Date of the Tender Offer for the purchase of all outstanding Ordinary Shares of Taro Pharmaceutical Industries Ltd. The Offer will now expire at 5:00 p.m., New York City time, on Friday, April 3, 2009, unless further extended or earlier terminated. ...
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Pronova BioPharma ASA today announces that it and its U.S. marketing partner GlaxoSmithKline Inc. have received a Paragraph IV Notice Letter dated March 17 2009 from Par Pharmaceutical Inc. (Par) advising that Par has submitted an Abbreviated New Drug Application to the US Food and Drug Administration for approval to market a generic version of Lovaza...
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Sepracor Inc. today announced that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against those companies who have filed abbreviated new drug applications with Paragraph IV certifications for generic copies of eszopiclone. Sepracor markets eszopiclone in the U.S. under the brand name Lunesta...
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A rash of U.S. manufacturing setbacks for some significant generic drugmakers stands to benefit large rivals such as Teva Pharmaceutical Industries Ltd and Mylan Inc by reducing competition....
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Drug maker Cubist Pharmaceuticals, Inc. said it filed a patent infringement lawsuit against Teva Parenteral Medicines, Inc., or TPM, Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd., alleging violation of its US patents related to daptomycin.
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Daiichi Sankyo Company has filed patent infringement litigation against 13 generics companies for the substance patent and usage patent for levofloxacin hydrate. ...
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Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration to market Sulfacetamide Sodium topical suspension, 10% (Lotion). ...
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At a time when biotech firms are struggling to stay alive, any little setback can drain a company's cash and limit prospects for raising more money....
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Teva Pharmaceutical Industries Ltd. today announced that the Food and Drug Administration (FDA or "Agency") has responded to their Citizen Petition regarding COPAXONE (glatiramer acetate injection). The FDA declined to review the CP "without comment on the approvability of any Abbreviated New Drug Application or New Drug Application for a glatiramer acetate injection drug product because it would be premature and inappropriate to do so at this time." The Agency's guidelines required a response to this Citizen Petition by March 26, 2009. ...
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Mylan Inc. today announced that it and/or a subsidiary have been sued in connection with four separate "first-to-file" Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration...
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In a bid to strengthen its position in emerging markets, British drugmaker GlaxoSmithKline is reportedly getting ready to acquire a minority stake in Africa's biggest generic drugmaker. According to press reports, Glaxo is preparing to buy a stake of between 10.0% to 25.0% in Aspen Pharmacare by swapping assets for Aspen shares, rather than paying up in cash....
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Mylan Inc. today announced its plans to purchase the remaining interest in Matrix Laboratories Limited from the minority shareholders pursuant to a voluntary delisting offer. Mylan, through a wholly-owned subsidiary, currently owns approximately 71.2% of Matrix and controls 76% of its voting rights. the Imapct of the transaction is anticipated to be accretive to Mylan's 2009 earnings...
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Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced U.S. Food and Drug Administration (FDA) approval of Azithromycin for injection, a semi-synthetic, macrolide antibiotic that is used to treat a wide variety of bacterial infections...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version for Ortho-McNeil's anticonvulsant Topamax (Topiramate) Tablets...
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The US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the Hatch-Waxman Act) there is no legally-approved regulatory pathway to bring FOBs to market in the US...
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Zydus Pharmaceuticals announced today that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Topiramate Tablets
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market generic Topamax, topiramate tablets...
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Reliance Life Sciences, which launched three biosimilars, or reverse-engineered versions of biotech drugs last year, will launch four more such drugs by next year...
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Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg...
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India's Ranbaxy Laboratories said on Monday it had received the U.S. Food and Drug Administration's approval to make and sell topirimate tablets...
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On March 30, 2009, FDA granted tentative approval for Abacavir sulfate and Lamivudine tablets, 600 mg/300 mg, manufactured by Matrix Laboratories Limited of Hyberdad, India, for use in combination with other antiretrovirals in the treatment of HIV infection...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the United States District Court for the District of Delaware has ruled that Watson's generic version of Concerta (methylphenidate hydrochloride extended-release tablets) does not infringe United States Patent No. 6,919,373 (the '373 Patent) and that the '373 Patent is invalid. The opinion, dated March 30, 2009, was issued by Judge Joseph Farnan, Jr., and applies to Watson's generic versions of Concerta(R) in the 18 mg, 27 mg, 36 mg and 54 mg strengths....
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Caraco Pharmaceutical Laboratories, Ltd. , a generic pharmaceutical company, announced today that all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall is being conducted with the knowledge of the Food and Drug Administration....
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Tuesday, Virginia-based Insmed Inc., said it completed the sale of all its assets in connection with its follow-on biologics business to a subsidiary of Merck & Co., Inc. for an aggregate purchase price of $130 million...
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