Sun Pharma Announces US Launch of Authorized Generics for Benicar, Benicar HCT, Azor and Tribenzor
Sun Pharmaceutical Industries Ltd announced that its wholly owned subsidiary has launched in US, the Authorized Generic (AG) versions for all strengths of Olmesartan Medoxomil tablets, Olmesartan Medoxomil-Hydrochlorothiazide tablets, Amlodipine Besylate-Olmesartan Medoxomil tablets, and Amlodipine Besylate-Hydrochlorothiazide-Olmesartan Medoxomil tablets. The launch is pursuant to a distribution and supply agreement between Sun Pharma’s wholly owned subsidiary and Daiichi Sankyo Inc., which grants the Sun Pharma subsidiary, exclusive rights to distribute these tablets in the US for a pre-determined period.
OptiNose is preparing to file its new chronic rhinosinusitis remedy for FDA approval by year’s end.
OptiNose is preparing to file its new chronic rhinosinusitis remedy for FDA approval by year’s end, with an eye to a potential launch in 2017. OptiNose-delivered fluticasone spray is a potential cure for patients suffering from chronic nasal and sinus problems. The drug is a widely used nasal steroid–but the delivery device is novel. Unlike traditional nasal inhalers, OptiNose’s device uses two pathways, one into the mouth and the other into the patient’s nostrils. Patients insert the device and exhale to dispense a dose.
Opiant Pharmaceuticals obtains development and commercialization rights for heroin vaccine
Opiant Pharmaceuticals has secured exclusive development and commercialization rights to the heroin vaccine invented by scientists at the Walter Reed Army Institute of Research (WRAIR) and the National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH). Researchers developed a vaccine candidate that induces antibodies that then bind to heroin in the bloodstream, thereby preventing the drug from crossing the blood-brain barrier and blocking the euphoria and addictive effects. As heroin is too small a molecule to induce antibodies on its own, scientists worked with organic chemists to join the heroin analog to a carrier protein in order to boost its immune-inducing effect.
Swissmedic approves Sobi’s Alprolix to treat haemophilia B
The Swiss Agency for Therapeutic Products, Swissmedic, has approved Sobi’s Alprolix (eftrenonacog alfa) for the treatment of haemophilia B. Alprolix has been developed for haemophilia B by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1. It is currently approved for the treatment of haemophilia B in the EU, Iceland, Liechtenstein and Norway, as well as the US, Canada, Japan, Australia, New Zealand and other countries.
Humira’s ppor performance triggers Q3 sales miss for AbbVie, but SG&A beat keeps EPS in line
For the third quarter, AbbVie bested analyst expectations in several areas. There was just one issue: The Company missed on revenue, and specifically on revenue for closely watched behemoth Humira. AbbVie’s top-line haul checked in at $6.39 billion, falling $173 million short of consensus estimates. And the company’s top seller was a big reason for the gap, with U.S. sales of $2.65 million underperforming expectations by $107 million–and ex-U.S. sales missing slightly, too. In the drug’s three major market segments, Humira is standing its ground despite increasing competition from next-gen meds and biosimilars of its anti-TNF rivals.
Boston Biomedical starts phase III study of Napabucasin
Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, announced dosing of the first patient in CanStem303C, a new global phase III study investigating napabucasin in combination with standard of care (Folfiri) in patients with previously treated metastatic colorectal carcinoma (mCRC). Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.
Martindale Pharma’s clobazam oral suspension receives approval from seven European countries
Martindale Pharma, UK-based international specialty pharmaceutical company, announced the regulatory approval of its clobazam oral suspension product, Epaclob. The suspension has received approval in France, Ireland, Germany and Italy and Silocalm in Denmark, Spain and Iceland following the successful completion of a decentralised procedure (DCP). Epaclob/Silocalm are based on Tapclob, and are approved in two strengths, 5mg/5ml and 10mg/5ml. They will be supplied in packs containing dosing syringes and dosage cups to facilitate accurate dosing and aid adherence to treatment.
Merck snagged a green light for Zinplava
The anti-infectives field is heating up–and Merck’s the latest Big Pharma player to win approval for a new entrant. The medicine meant to reduce resistance of Clostridium difficile infection in adults. Zinplava will join a Merck anti-infectives portfolio that took shape with its early 2015 purchase of Cubist Pharmaceuticals. Zinplava also faces the prospect of competition not only from other drugs, but also from vaccines that might prevent C. Diff altogether. Pfizer and Sanofi are each working on versions, and smaller vaccine makers are in the mix, too.
Nanotechnology to improve HIV drug therapies
Researchers at the University of Liverpool, UK, are exploring the use of nanotechnology to improve administration and availability of drug therapies to HIV patients. A recent investigation conducted by Pharmacologist professor Andrew Owen and Materials Chemist professor Steve Rannard, has discovered that HIV patient groups have shown their desire to switch to nanomedicine alternatives. They are working on the development of new oral therapies, by using solid drug nanoparticle (SDN) technology. The SDN technology is anticipated to reduce both the dose and the cost per dose.
Biocon’s Malaysia insulin plant will be ready for commercial production in H2
India’s Biocon has been working for six years on a massive, $250 million facility to manufacture insulin in Malaysia and says it will soon produce commercial product there. The company’s plant is in Nusajaya, which was certified by authorities this year, and has 400 employees and represents the largest foreign investment made in Malaysia’s biotech sector to date. It also is Biocon’s first overseas biopharma manufacturing and research facility.
FDA Approves Janssen’s STELARA for the Treatment of Adults With Moderately to Severely Active Crohn’s Disease
Janssen Biotech Inc. received approval from the U.S. FDA for STELARA (ustekinumab), used for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older). The drug is for the patients who have failed or were intolerant to treatment with immune-modulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers. Janssen will work closely with payers, providers and pharmacy benefit managers to ensure STELARA® is broadly accessible and affordable for patients.
Novartis announces AMG 334 significantly reduces monthly migraine days in people with episodic migraine
Novartis announced positive topline results from ARISE, the first Phase III study evaluating the efficacy and safety of monthly subcutaneous AMG 334 (erenumab) 70mg in episodic migraine prevention. The Phase III study met its primary endpoint, showing a statistically significant reduction in monthly migraine days vs placebo.
AbbVie’s Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation
AbbVie, a global biopharmaceutical company, got Breakthrough Therapy Designation (BTD) from the U.S. FDA for pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P), which is used for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor. The BTD is supported by positive results seen in AbbVie’s Phase 2 MAGELLAN-1 clinical study.
PaizaBio Gains CFDA Approval to Expand Fill/Finish Capacity
PaizaBio gained approval from China’s FDA (CFDA) to add new aseptic injectable production capability at it production facility in Hangzhou, China. This expansion will increase the company’s annual fill/finish capacity from 300 million units to 400 million, including vials, pre-filled syringes and cartridges. The capacity will focus on small molecule drugs for clinical trials and small batch production and the company anticipates reaching full-scale production by 1Q17.
WuXi Biologics completes construction of Asia’s largest perfusion biologics manufacturing facility using disposable bioreactors
WuXi Biologics, an open-access R&D capability and technology platform company, has announced the opening of a new commercial-scale cGMP biologics perfusion manufacturing facility in Wuxi city, China. The new facility accommodates two 1000L disposable bioreactors for perfusion processes and is the largest perfusion biologics manufacturing facility to date in Asia implementing disposable bioreactors.
US FDA grants approval for Novartis’ Ilaris to treat Periodic Fever Syndromes
Novartis received approval to market its Periodic Fever Syndrome drug Ilaris (cancakinumab). The drug targets the syndrome, and will be used to treat a group of diseases that cause serious recurrent fever and pathogenic inflammation through non-infectious activation of the immune system. Ilaris inhibits Interleukin-1 (IL-1) beta, and is already approved in the US to treat Cryopyrin-Associated Periodic Syndromes (CAPS) and Systemic Juvenile Idiopathic Arthritis (SJIA).
Sanaria receives FDA fast-track designation for malaria vaccine
PfSPZ, the malaria vaccine of Sanaria, has received fast-track designation from the US Food and Drug Administration (FDA).PfSPZ is currently in clinical trials that are intended to finalise an immunisation regimen to be taken forward into pivotal Phase III clinical trials. If successful, the clinical trials provide the necessary data for licensing the vaccine, according to the company.
Sanofi and Regeneron’s next wannabe blockbuster tagged ‘priority’ by Regulators
FDA has accepted the application for atopic dermatitis candidate dupilumab, from Sanofi and Regeneron, and have given it a priority review tag that should hasten its trip to approval. Dupilumab has already shown it can beat out those topical steroids, too. In June, its makers rolled out Phase III data showing that a dupilumab/corticosteroid combo topped steroids alone. analysts see dupilumab generating more than $2.5 billion a year–with some predicting up to $4 billion or $5 billion.
Allele receives NIH grant to develop new antibody therapy for Alzheimer’s disease
Allele Biotechnology and Pharmaceuticals (Allele) has secured a grant from the US National Institutes of Health’s (NIH) National Institute on Aging to develop a new antibody therapy for Alzheimer’s disease. Allele will develop a panel of antibodies that identify this protein, one of which would be used as a therapeutic drug candidate. The antibodies will feature a distinct shape and size, allowing them to pass the blood-brain barrier to reach the critical areas of the brain. Allele researchers also aim to modify and engineer each antibody to enhance its therapeutic potential.
GSK appoints its first female CEO
Emma Walmsley has been appointed as GlaxoSmithKline‘s new CEO, and has broken the mould as she is the first woman to lead a top global drug maker, being a consumer brands guru rather than a prescription medicines expert. Walmsley’s appointment suggests GSK will continue the diversified strategy pioneered by outgoing CEO Andrew Witty. “Obviously, R&D is the beating heart of our company and our success is and will continue to be defined most fundamentally by the strength of our pipeline,” she said in an in-house video recorded to mark her appointment.
Johnson & Johnson to Buy Abbott’s Vision Unit for $4.33B
Johnson & Johnson announced that it will acquire Abbott Medical Optics for $4.325 billion. The deal is expected to close in the first quarter of 2017. The deal comes as JNJ plans to grow its vision business by entering into the cataract surgery market, apart from its Acuvue contact lenses. Abbott has decided to sell this part of business so that it can focus more on treatment for heart and arteries and disease testing equipment.
Essai Launches Collaborative R&D Unit in Boston Area
Eisai Inc., the U.S. subsidiary of Japan’s Eisai Co., Ltd., announced that it is launching a research-and-discovery unit in the Boston area. The new unit will be called the Eisai Andover Innovative Medicines (AiM) Institute. It will target three therapeutic areas, immuno-dementia, immuno-oncology, and autoimmune indications. Within immuno-dementia, AiM will focus on a subset of dementia patients whose disease is driven by immune dysfunction. In immuno-oncology, it will focus on discovering precision immunotherapies that target myeloid lineage cells. In autoimmune studies, it will look at toll-like receptors and prostaglandins to develop therapies for diseases like systemic lupus erythematosus (SLE).
Novartis intensifies marketing plan for Entresto
Novartis on Monday intensified its bid to convince doctors to prescribe its heart failure drug Entresto, releasing an analysis that concluded the medicine contributed to higher quality of life scores compared with an older drug. Launched with much fanfare last year, Entresto sales have so far disappointed investors and the company, forcing Novartis to spend hundreds of millions more on marketing as it seeks to hit a modest target of $200 million in revenue from the drug this year.
U.S. FDA approves Bayer contraceptive device Kyleena
The U.S. Food and Drug Administration approved Bayer AG‘s hormonal contraceptive device, Kyleena, to prevent pregnancy for up to five years. Kyleena, which will be available from October, is a long-acting reversible contraceptive (LARC), a category of potent contraceptives that has returned to popularity. LARCs, including IUDs and implants, are more effective than other contraceptives such as pills and patches, and are nearly as effective as sterilization, according to the U.S. Centers for Disease Control and Prevention.
Roche’s drug candidate for Multiple Sclerosis touted to be better than Merck’s Rebif
The much anticipated multiple sclerosis drug from Roche, ocrelizumab, has overtaken Merck’s Rebif according to the results of Phase III data, and has also shown great stats that could prove that it might have an edge in the hotly contested market. If the candidate is approved, Ocrevus is expected to be a tough rival, given its data in progressive MS; no other MS drug has yet proven to be effective in those hard-to-treat patients, and that success is expected to help Ocrevus in the market as well.
Risk info on cancer drugs on various websites skimpy, may give patients false hope
The researchers from the Office of Prescription Drug Promotion and RTI International analyzed 65 sites for branded cancer meds, and found out that almost all of them cited specific numbers on their effectiveness and side effects- which is not enough. It has not come as a surprise as the regulations require disclosure of effectiveness as well as side effects. The FDA agency has also found that these sites list far more treatment benefits as compared to risks, and are seriously harming the patients by providing incomplete information.
The FDA norms likely to punch a Rs 5,000 crore hole in Indian Pharma Industry
The Compliance to the US Food and Drug Administration norms might turn out to be a costly affair for Indian Pharma companies. The main reflection of this is in the way legal and professional costs have surged for many companies, more than some’s annual revenues. For 135 listed pharma companies, this has jumped threefold to Rs 5,071 crore in past five years, based on their annual reports.
Takeda sets aside $15B for U.S. M&A deals
Takeda has shown a great shift in R&D philosophy after it set aside the major part of drug research and development responsibilities and took up other development deals in oncology, vaccines and CNS. Also, it has set aside close to $15 billion for M&A deals in the USA, to buy companies that fit in with the vision Takeda has for itself.