Generics Industry News Search
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November 2010 News Archive |
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Impax Laboratories, Inc. today announced that it has initiated litigation against Shire LLC and Shire Laboratories, Inc. in order to resolve recent and recurring supply issues of its authorized generic version of Adderall XR. The Company is seeking to compel Shire to deliver duly ordered amounts of product under the parties' Settlement Agreement and License and Distribution Agreements. ...
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Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Impax Laboratories, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 4 mg guanfacine hydrochloride extended release tablet, INTUNIV....
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Anchen Pharmaceuticals, Inc. confirmed today that it has initiated a challenge of a patent listed by Abbott Laboratories in connection with its Zemplar, 1 mcg, 2 mcg, and 4 mcg oral capsules drug products....
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Australia's Parliamentary Secretary for Health and Ageing, Catherine King, yesterday (November 1) announced a key milestone in reforming the regulation of prescription medicines in Australia...
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Drug firm Lupin today said it has been granted final approval by the United states Food and Drug Administration for antihistamine Desloratadine tablets, used for treating allergies. ...
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Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has entered into an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc., to market the authorized generic version of Concerta (methylphenidate hydrochloride extended-release tablets). Watson will launch its authorized generic of Concerta on May 1, 2011. Concerta is indicated for the treatment of attention deficit hyperactivity disorder....
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On 1 November 2010, the US Court of Appeals for the Federal Circuit affirmed the District Court's issuance of a preliminary injunction barring Apotex from launching a generic version of AstraZeneca's PULMICORT RESPULES (budesonide inhalation suspension) in the US. The Preliminary Injunction issued by the District Court in May 2009 therefore remains in place. No trial date for the patent litigation has been set....
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Terence Ryan, a senior vice president at iBio Inc., a Newark biopharmaceutical company, will testify today before a panel of the U.S. Food and Drug Administration that is attempting to create review standards for generic copies of drugs developed from biological materials...
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Pharma Major, Lupin Ltd announced today that its U.S subsidiary, Lupin Pharmaceuticals, Inc. has been granted final approval for Suprax (Cefixime) Chewable Tablets, 100 mg, 150 mg and 200 mg from the U.S. Food and Drug Administration....
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Sandoz, the global leader in biosimilars, has testified on behalf of the Novartis Group of companies at a key regulatory public hearing inviting input on how best to implement the new US biosimilar regulatory pathway....
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Companies that copy biotechnology drugs, led by Teva Pharmaceutical Industries Ltd., will be able to bypass a new process set up by the U.S. health overhaul to get their products approved, regulators said. ...
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At a special meeting today, Penwest Pharmaceuticals shareholders voted to approve the merger of West Acquisition Corp., an indirect wholly owned subsidiary of Endo Pharmaceuticals Holdings, with and into Penwest and voted to approve the "Agreement and Plan of Merger," dated Aug. 9, 2010, by Penwest, West and Endo. ...
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Pharmaceutical companies in the Asia Pacific region are increasingly adapting their business models from the production of generic drugs towards more high-risk, high-return research and development, according to a new report released by CMR International, a Thomson Reuters business....
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Actavis today announced the launch of Mycofenolatmofetil Actavis, immediately after the patent expired in the UK, Netherlands, Germany, Sweden, and Finland....
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Teva said that it intends to file ten products, six of which are new brands, for approval in the US and Europe by 2015...
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Watson Pharmaceuticals, Inc. earned $0.21 per diluted share on a GAAP basis in the September-ending third quarter of 2010, down approximately 60 percent from $0.54 in the same three months of last year...
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A stoush has broken out between the makers of generic and brand name drugs over legislation that will change the Pharmaceutical Benefits Scheme....
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GlaxoSmithKline Plc's top-selling lung drug Advair is set to enjoy a longer lease of life than widely expected, due to the difficulties facing generic companies seeking to make cut-price copies....
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Safeguard Scientifics, Inc., a holding company that builds value in growth-stage life sciences and technology companies, today announced that partner company Avid Radiopharmaceuticals, Inc. has signed a definitive merger agreement to be acquired by Eli Lilly and Company....
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Wyeth, a unit of Pfizer Inc., beat back a challenge from generic drug makers against the patent on the extended-release form of its antidepressant Effexor in Australia....
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Shire plc, the global specialty biopharmaceutical company, announces that its wholly owned subsidiary Shire Holdings Luxembourg S.a.r.l. has now acquired all of the issued shares and warrants of Movetis NV....
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Israel-based Teva Pharmaceutical Industries will pay $163 million to raise its stake in Mediwound to 51 percent to gain access to wound-healing products....
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NeoPharm, Inc., a biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for cancer and other diseases, today announced it has completed its merger with Insys Therapeutics, Inc., a Phoenix, AZ based pharmaceutical company....
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Merck & Co., Inc. said today that a federal appellate court ruled in its favor in a TEMODAR patent infringement suit against Barr Laboratories, an affiliate of Teva Pharmaceuticals....
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In recognition of excellence on the international stage GenericsWeb, a supplier of premium patent intelligence products to the Pharmaceutical Industry, has been awarded the New South Wales export award in the Small to Medium Business Services category. Beating five other NSW category finalists, the win progresses GenericsWeb to compete as a finalist of the Australian Export Awards ...
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Shire plc, the global specialty biopharmaceutical company, announces that the U.S. Court of Appeals for the District of Columbia Circuit has affirmed the ruling of the U.S. District Court for the District of Columbia and the U.S. Food and Drug Administration to grant five-year New Chemical Entity exclusivity to lisdexamfetamine dimesylate, currently marketed by Shire U.S. Inc. under the name VYVANSE....
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In a series of letters, the U.S. Patent and Trademark Office has clarified when patents covering certain drug products are eligible for a Patent Term Extension. The PTO issued the letters as a result of recent decisions from the U.S. Court of Appeals for the Federal Circuit in PhotoCure v. Kappos, 603 F.3d 1372 (Fed. Cir. 2010) and Ortho-McNeil Pharm., Inc. v. Lupin Pharms., Inc., 603 F.3d 1377 (Fed. Cir. 2010). ...
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Lavipharm announces the launch of its proprietary fentanyl transdermal system in the Greek pharmaceutical market by the international pharmaceutical company Pfizer. The product will be promoted by Pfizer's sales force and will be marketed under Lavipharm's trademark Dolfen. Lavipharm already markets the product in Greece since 2007 under the brand name Fentadur. ...
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AstraZeneca Plc, facing patent expirations on its top-selling medicines, sees room for more cost cuts in marketing, sales and other areas to shore up profits, its chief executive said on Wednesday....
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Labopharm Inc. today announced that on November 11, 2010 it received notice from Actavis South Atlantic LLC advising that Actavis has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 150 and 300 mg generic versions of OLEPTRO (trazodone hydrochloride extended-release 150 and 300 mg tablets) in the United States...
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Privately-held, US clinical stage pharmaceutical company Aires Pharmaceuticals had a successful fundraising day yesterday, completing a $20 million series B financing and further bolstering its cash reserves by entering into an agreement with Swiss drug major Novartis, granting the latter an exclusive option to acquire Aires following the successful completion of a Phase II clinical study of Aironite, an inhaled nitric oxide prodrug to treat pulmonary arterial hypertension....
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In a first-ever survey on Teva Pharmaceutical Industries Ltd. entitled "Strong company but Copaxone is an overhang," Morgan Stanley Research is unenthusiastic on Teva's share price and has given the company an equal-weight stock rating...
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Ranbaxy Laboratories sued AstraZeneca Plc in the UK over claims that its European patents for the best-selling ulcer treatment Nexium are invalid, two years after settling a related US case....
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Headquartered in Mumbai, Lupin has transformed itself into one of the largest generic companies based out of India. Ranking fifth in the domestic market, the company has made remarkable strides in the US market with a generic as well as specialty formulations presence...
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Actavis Group hf, an Iceland-based maker of generic drugs, and Bioton SA, a Polish insulin producer, plan to sign a cooperation agreement by the end of this year, Bioton said in a regulatory statement yesterday. ...
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Genzyme Corp. started talks with Takeda Pharmaceutical Co. to try to sell itself for more than $18.5 billion, the Mail on Sunday reported, citing a person familiar with the matter....
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Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced it has launched a two-gram vial of gemcitabine hydrochloride for injection. The oncology medication is a generic version of Eli Lilly's Gemzar, which posted 2009 U.S. sales of nearly $750 million for the full range of standard presentations. ...
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Actavis has filed an abbreviated new drug application with the US Food and Drug Administration for marketing the generic versions of Oleptro (trazodone hydrochloride extended-release 150 and 300mg tablets) in the US....
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Moving to expand its Biologics product offerings, Medtronic, Inc., announced today it has completed the acquisition of Osteotech, following payment of $6.50 per share in cash for each share of Osteotech stock, with a total transaction value of approximately $123 million...
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Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration has granted final approval of the Company's Abbreviated New Drug Application for the generic version of Allegra-D(R) (Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release) 60mg/120mg tablets. The Company is preparing for product launch through Global Pharmaceuticals, Impax's generic division. ...
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Otsuka Pharmaceutical Co., Ltd. and Otsuka Holdings, Co., Ltd., the parent company of Otsuka Pharmaceutical Co., Ltd., announced today that the U.S. District Court for the District of New Jersey issued its judgment dated November 15, 2010 in favor of Otsuka Pharmaceutical Co., Ltd. in its patent litigation against several companies seeking FDA approval to market generic copies of Abilify....
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Drugmaker Eli Lilly and Co. said a federal court judge upheld a patent protecting one of its best-selling drugs, the cancer treatment Alimta....
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Inhaled drugs specialist Vectura sought to bolster confidence in the potential for a generic rival to Glaxo's lung drug Advair in Europe on Tuesday as its partner Sandoz ordered a first batch of Vectura inhaler devices....
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PFIZER, Inc. launched its local generic drug business yesterday in a bid to become one of the top three firms in the lucrative off-patent medicine industry in the Philippines...
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ISTA Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration has granted the Company three years of marketing exclusivity for BROMDAY (bromfenac ophthalmic solution) 0.09%, as provided under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act....
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted it an approval for its Abbreviated New Drug Application to market a generic version of Schering Plough's Clarinex tablets, 5 mg....
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application to market a generic version of once-a-day Tiazac extended release capsules....
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Amgen Inc., the world's largest biotechnology company, is considering a takeover offer for Actelion Ltd. to gain new medicines for rare diseases, and may approach the Swiss drugmaker as early as this week, said two people with knowledge of the matter. ...
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A federal judge has dismissed the manufacturers of brand name Reglan from a tardive dyskinesia lawsuit filed by a plaintiff who only took generic forms of metoclopramide....
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Cardinal Health today announced plans to acquire Kinray, Inc., a leading pharmaceutical distributor serving the New York metropolitan area, for $1.3 billion in an all-cash transaction that will significantly expand its ability to serve retail independent pharmacies in the northeastern United States...
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Synthon is announcing today that it has successfully concluded multiple registration procedures for Tamsulosin extended release tablets. Regulatory clearance has been obtained for Synthon's product in all relevant European countries...
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Cephalon Inc., maker of the sleep-disorder drug Provigil, can't block Mylan Inc. and Orchid Chemicals & Pharmaceuticals Ltd. from selling generic versions of the drug in Britain before a patent trial, a judge ruled...
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Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne's decision and requested that they voluntarily remove their products as well...
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Johnson & Johnson's Tibotec unit and the U.S. government separately sued Mylan Inc. and Lupin Ltd. to prevent sales of a generic version of the HIV medicine Prezista....
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Dr. Reddy's Laboratories announced today that it has launched Zafirlukast tablets (10 mg and 20 mg), a bioequivalent generic version of AccolateR in the US market...
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Par Pharmaceutical Companies, Inc. today announced that it has entered into an exclusive supply and distribution agreement with AstraZeneca in the U.S. to distribute the authorized generic version of AstraZeneca's Accolate(R) (zafirlukast)...
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL(R) (Colesevelam HCl) for Oral Suspension, 3.75 gm/packet and 1.875 gm/packet...
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Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration has granted tentative approval of the Company's Abbreviated New Drug Application for generic version of Cymbalta(R) delayed-release (duloxetine hydrochloride) 20, 30 and 60 mg capsules...
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Sun Pharmaceutical Industries has lost an opportunity to launch the generic version of a schizophrenia drug that had generated revenue of $4 billion (Rs 18,150 crore) in the United States market in 2009. It, with some other generic drug majors, lost a patent battle against Japanese drug major Otsuka and its US business partner, Bristol Myers Squibb, last week....
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The Southeast Asian pharmaceuticals industry is in a state of transition and the generic drug market is slowly gaining more attention from both patients and governments....
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The US Patent & Trademark Office has issued US patent 7,833,998 entitled, 'Oral Neurotherapeutic Cephalosporin Sulfoxide and Sulfone-containing Compositions' to Rexahn Pharmaceuticals...
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GlaxoSmithKline plc and Dr. Reddy's Laboratories today announced that the companies have signed an agreement relating to GSK's United States oral penicillin facility and product portfolio....
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(Teva) are pleased to announce the launch of a generic version of Prednisolone enteric-coated tablets. ...
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Today, CNS Therapeutics announced the FDA approval of Gablofen (baclofen injection) for use in the management of severe spasticity, giving healthcare providers a new, easy-to-administer and cost-effective intrathecal baclofen treatment option. Severe spasticity is a movement disorder affecting more than 500,000 patients in the U.S. alone and is often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma and stroke...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for an Abbreviated New Drug Application to market a generic version of Cymbalta, duloxetine hydrochloride delayed-release capsules...
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The sale of anti-obesity medicine Sibutramine has finally been banned in India following reports of adverse cardiac effects. The Drug Controller General of India said that the ban would ensure that the drug was neither manufactured nor sold in India...
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It has been 22 years since the Generics Law in the Philippines was passed but Filipinos are still cautious about buying and using generic drugs....
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GlaxoSmithKline will seek to defend the patent on its top-selling lung drug Advair in a Dutch court on Friday in the latest in a series of legal skirmishes across Europe over the inhaled medicine....
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed in connection with SIMCOR(R) (niacin/simvastatin) extended-release tablets, 1000/20 mg. ...
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Pronova BioPharma ASA today announces that it and its US marketing partner GlaxoSmithKline Inc. have received a Paragraph IV Notice Letter dated 23 November 2010 from Apotex Inc...
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European regulators on Friday set out broad guidelines for the approval of biosimilar antibody drugs, including lower hurdles than for new medicines and allowing the possibility of different diseases being addressed by the same copy antibody...
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The European Medicines Agency has published draft regulations for biosimilars, opening a market for Teva Pharmaceutical Industries Ltd. and other generic drug companies that develop generic versions of biological drugs...
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Ranbaxy Laboratories will launch a low-cost version of Alzheimer's drug Aricept in the US next week generating revenues of around $200 million or more over a six month period...
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About Court Report: Each week we will report briefly on recently filed biotech and pharma cases...
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Impax Laboratories, Inc. today confirms that Alza Corporation has filed suit for patent infringement against Impax in the United States District Court for the District of Delaware in connection with Concerta(R) (methylphenidate hydrochloride) extended-release 54 mg tablets...
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Perrigo today announced that its licensor and supplier Synthon has received final approval from the U.S. Food and Drug Administration for Levocetirizine tablets, a generic version of Xyzal tablets from UCB/Sepracor, which is marketed in the U.S. by Sanofi-Aventis...
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Actavis today announced the launch of a Docetaxel single vial, immediately after the patent expired in major European markets....
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Over-the-counter drug maker Perrigo Co. said Monday that it is now selling a generic version of Bayer HealthCare's Aleve Liquid Gels...
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GenericsWeb recently published an article based on its proprietary patent intelligence for Emend/Ivemend (Fosaprepitant), Merck's drug for the prevention of chemotherapy induced nausea and vomiting. ...
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