Government Plans Two New Labs for Testing Drug Samples
New Delhi: In a move to ensure safer medicines, the Centre plans to designate two new laboratories — in Mumbai and Chennai — as ‘appellate testing laboratories’, to check drug samples collected by regulators as part of market surveillance and plant inspections. While the labs in Chennai and Mumbai are fully equipped, they have so far been used by state regulators. The central regulator will upgrade them to ensure they are prepared to deal with demands. The new laboratories will add to the government’s capacity to test samples as currently there is only one such central drug testing lab in Kolkata. The central facilities are expected to improve standards and also be less susceptible to manipulation as they will function under government supervision. The different laboratories will enable samples being randomly sent to any of the facilities for testing. Apart from random sampling from the market and products that seek approvals from the regulator, the central drugs standard control organisation also undertakes a massive exercise annually, which involves collection of around 50,000 samples from across the country to check counterfeiting and ensure quality of medicines. All these samples were so far sent to the Kolkata laboratory. Now, with government planning to increase frequency of inspections as well as fast track process to process approvals in time, capacity and fidelity of testing has emerged as a major concern. The proposal is part of the agenda to be taken up by the drug regulatory Drugs Technical Advisory Board for final approval in its upcoming meeting by end of this month. In absence of authentic data, regulators struggle to keep a check on quality of products being sold to patients. Quality assumes significance as India is the largest supplier of low-priced generic medicines to the world and has faced strong criticism on standards.


Cipla Receives Final Approval for Generic Isoproterenol Hydrochloride Injection
Cipla Limited (“Cipla”), recently announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Isoproterenol Hydrochloride Injection USP, 0.2mg/mL, single-use sterile Ampoule from the United States Food and Drug Administration (US FDA).
Cipla’s Isoproterenol Hydrochloride Injection USP, 0.2mg/ml, ampoule is AP-rated generic therapeutic equivalent version of Hospira Inc’s Isuprel® Injection, 0.2mg/ml and is indicated for the treatment of…
Mild or transient episodes of heart. block that do not require electric shock or pacemaker therapy. Serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation).
Use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available. Bronchospasm occurring during anesthesia.
As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock.
According to IQVIA (IMS Health), Isuprel Injection and its generic equivalents had US sales of approximately $148M for the 12-month period ending April 2018.


Cipla Aiming at $1-billion Domestic Turnover in 2018-19
India’s fourth-largest drug firm, Cipla, is bullish on the domestic market and is aiming to cross the billion dollar consolidated revenue mark for its consolidated revenue in the current financial year. The company reported revenues of Rs. 15,219-crore, growing 6 per cent, with income from the India operations seeing a 6.3 per cent jump at Rs. 5,687-crore in FY18. “In terms of the domestic business we are on a strong footing as growth was in healthy double digits,” Cipla global CFO Mr. Kedar Upadhye said at an earnings conference recently. “We are quite confident and we are set for a billion dollar consolidated revenue in the domestic market in FY19,” he added.


Ferring Launches Work on Facility in Hyderabad
Hyderabad: European pharma major Ferring Pharmaceuticals on recently launched the work on its research and development laboratory and manufacturing facility at Genome Valley here. Ferring plans to complete the project in three phases with a total proposed investment of $250 million. Ferring Pharmaceuticals, a Switzerland-based Euro 2 billion research-driven specialty biopharmaceutical group, joined the list of European pharma majors to invest in a facility in Genome Valley. The new facility will also add to group's global R&D capabilities and will cater to building a pool of novel research for emerging healthcare challenges around the world, said a statement. Ferring, which is also a leader in reproductive medicine and women's health with strong presence in specialty areas within gastroenterology and urology, has manufacturing facilities across Europe, North America, South America, China and India marketing its products in over 110 countries. The company established its Indian subsidiary in 1997 and has thus far established a manufacturing facility, an R&D centre and commercial operations in Maharashtra. Ferring India CEO Suresh Pattathil mentioned that Ferring's association with Hyderabad began after the group's chairman Dr. Fredrick Paulsen expressed a strong interest in investing in the city on back of progressive governance and forward-looking industry policies, and presence of the right infrastructure, skilled manpower pool for R&D and manufacturing. Telangana's Minister for Industries, K.T. Rama Rao, who laid the foundation stone, said Ferring joined top European companies like Novartis, GSK, Chemo and Lonza in setting up the facilities in Genome Valley, which has emerged as one of the leading life sciences clusters in Asia.


Aurobindo Pharma Recieves USFDA Nod for Anti-Bacterial Injections
New Delhi: Drug firm Aurobindo Pharma recently said it has received final approvals from the US health regulator to manufacture and market Oxacillin for Injection used for treating bacterial infections in the American market. The company has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Oxacillin for Injection USP, packaged in 1g and 2g vials and Oxacillin for Injection USP 10g/vial pharmacy bulk package, Aurobindo Pharma said in a statement. The products are ready for launch, it added. These abbreviated new drug applications (ANDAs) have been approved out of the company's facility in Hyderabad and will be marketed and sold by its US subsidiary AuroMedics Pharma LLC, Aurobindo Pharma said. "Oxacillin for Injection USP is a sterile semi-synthetic penicillin (SSP) indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug," it added. Aurobindo now has a total of 174 ANDA approvals, the company said. Shares of Aurobindo Pharma were today trading at Rs 195.55 apiece in the afternoon trade on BSE, up 1.53 percent from their previous close.


Dr. Reddy’s Ties up with UCB to Market Epilepsy Drug in India
Hyderabad: Dr. Reddy’s Laboratories Ltd, and UCB, a biopharmaceutical company, recently announced they have entered into a distribution and co-promotion agreement for Briviact (Brivaracetam) for India. According to a press release issued by Dr Reddys, the agreement grants it the exclusive right to distribute Briviact in India. The drug is approved as an adjunctive therapy for the treatment of partial-onset seizures in epilepsy patients who are 16 years of age and older. Dr Reddy’s CEO - Branded Markets (India and Emerging Markets), M V Ramana, said “In our endeavour to make innovative medicines accessible to patients in India, we are excited to partner with UCB India for Briviact, a novel treatment for epilepsy that will make a difference to the lives of patients living with epilepsy.” UCB Neurology Patient Value Unit, head of International Markets, Max Bricchi said “This partnership is another important step towards us providing value together to patients by making Briviact available as an additional treatment choice for epilepsy.” Epilepsy is the second most common neurological conditionand as per a recent study, an estimated 70 million people suffer from it worldwide while there are over 12 million people suffering from epilepsy in India, which contributes to nearly one-sixth of the global burden, the release said. Dr Reddys share closed at Rs 2329.80, up by 2.80 per cent over previous close on the BSE.


Glenmark Gets USFDA Nod for Contraceptive Drugs
New Delhi: Glenmark Pharmaceuticals has received final approval from the US health regulator for generic versions of Loestrin tablets, used to prevent pregnancy. “Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Hailey 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1.5 mg/30 mcg) and Hailey Fe 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets, USP and Ferrous Fumarate tablets, 1.5 mg/30 mcg),” the company said in a BSE filing. The approved products are generic versions of Allergan Pharmaceuticals’ Loestrin 21 1.5/30 and Loestrin Fe 1.5/30 tablets. For the 12 months to April 2018, the Loestrin 21 1.5/30 and Leostrin Fe 1.5/30 tablets market achieved annual sales of approximately $24.2 million and $41.3 million respectively, Glenmark said, citing IQVIATM sales data. The company’s current portfolio consists of 137 products authorised for distribution in the US marketplace and 61 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA. The company’s stock was trading at Rs 528.10, down 0.28 per cent, on the BSE


Sun Pharma Receives Prestigious CSR Award
Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" or the "Company" including its Indian subsidiaries) received a Corporate Social Responsibility (CSR) Award from the Federation of Gujarat Industries (FGI) for outstanding contribution in the field of CSR. The award was presented to Sun Pharma for its CSR efforts in the areas of healthcare, education, safe drinking water, sanitation & hygiene, environment conservation, rural development, disaster relief and malaria elimination. The Company's CSR initiatives benefited around 1.2 million people from 3800 villages spread over 11 states in India last year (2017-18). FGI instituted the biennial FGI Awards for excellence in 1993 to honour and felicitate individuals, organizations, institutes and industries in 14 different categories. The award was presented by Smt. Maneka Gandhi, Hon'ble Union Cabinet Minister for Women & Child Development, Govt. of India at the 15th FGI Awards function organised at Vadodara, Gujarat. On behalf of Sun Pharma, the award was received by Dr. Azadar Khan, Sr. VP - Corporate Relations. Earlier in the year, Sun Pharma was conferred with the 'CSR Leadership Award' for making a positive impact in the lives of marginalised & backward communities. The award was given by World CSR Congress.


Sun Pharma Receives EIR for its Halol Facility
Mumbai: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) recently announced that it has received the Establishment Inspection Report (EIR) from the US FDA for the inspection conducted at its Halol facility (Gujarat, India) during the period February 12-23, 2018. The agency concluded that the inspection is now closed and the issues contained in the Warning Letter issued in December 2015 have been addressed. Commenting on the development, Dilip Shanghvi, Managing Director, Sun Pharma said, “This is an important development for Sun Pharma. We remain committed to following the highest levels of quality and 24x7 cGMP compliance at all our manufacturing facilities globally.”.


Polio Virus New Weapon in Fight Against Cancer
One of the world’s most dreaded viruses has been turned into a treatment to fight deadly brain tumours. Survival was better than expected for patients in a small study who were given genetically modified polio virus, which helped their bodies attack the cancer, doctors report. It was the first human test of this and it didn’t help most patients or improve median survival. But many seemed to have long-lasting benefit: About 21% were alive at three years versus 4% in a comparison group of previous brain tumour patients. Brain tumours called glioblastomas often recur after initial treatment and survival is usually less than a year. Doctors at Duke University wanted to take advantage of the strong immune system response polio spurs to try to fight cancer. With the help of the National Cancer Institute, they modified polio virus so it would not harm nerves but still infect tumour cells. The one-time treatment is dripped directly into the brain through a thin tube. Inside the tumour, the immune system recognises the virus as foreign and attacks. The study tested the modified polio virus on 61 patients whose tumours had recurred after initial treatments. Median survival was about a year, roughly the same as for a small group of similar patients given other brain tumour treatments at Duke. After two years, the polio virus group started faring better. Eight of the 35 patients who were treated more than two years ago were alive as of March, as were five out of 22 patients treated more than three years ago. Stephanie Hopper (27) of South Carolina was the first patient treated in the study in May 2012. “I believe that it was the cure for me,” she said. Her only lasting symptom has been seizures, which medicines help control. “Most people wouldn’t guess that I had brain cancer.”



Intas Pharmaceuticals to be the First to Launch Pegfilgrastim Biosimilar in Europe
Intas Pharmaceuticals’ wholly owned subsidiary - Accord Healthcare is set to be the first integrated player to launch a pegfilgrastim biosimilar across Europe after being given Green Light for Pelgraz® (pegfilgrastim) by CHMP. The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Accord’s Pelgraz (pegfilgrastim), pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe. Current market for pegfilgrastim in EU is about half a billion Euro. Intas Pharmaceuticals will manufacture Pelgraz in its own state of the art production facility. Intas has deep experience with biosimilar medicines. As of July 2018 Intas has 12 different Biosimiliars approved in various markets across the world. This reflects a long-standing commitment of Intas to develop, manufacture and market biosimilars. The company's dedicated biologic manufacturing plant was the first in India to gain and maintain EU GMP approval. Intas started its biosimilar program 15 years ago, and has already launched 12 biologics in India. Intas was the first ever Indian company to launch a biosimilar in Europe and till date remains the only India-based company to have a biosimilar product approved in European markets. In a short span Intas has garnered about 15 % market share for its biological product “Accofil” (Filgrastim) in EU. Binish Chudgar Vice Chairman and Managing Director of Intas Group, “Intas/Accord launched its first European approved biosimilar product, Accofil, in 2015 and despite being the 6th entrant has become a leading supplier of this vital medicine. Since then the product has been used over 2 million times and Intas has gained valuable experience in bringing biosimilar medicines to market. Our continued focus on bringing biopharmaceuticals to Europe has enabled us to be a first to launch a pegfilgrastim, and as a first mover we expect to gain an even bigger market share with Pelgraz.” Emilio Rivera, COO of Intas Biotech,” At Intas Biotech, our mandate is to develop, manufacture and market Biosimiliars of world class quality. We would like our products to be accessible to as many patients as possible. With this approval it brings Intas one step closer in realizing its vision of Biosimiliars for Billions.


Neovii & Mundipharma Confirm In-licensing Agreement for the Development and Promotion of Grafalon(R) in China and Japan for Solid Organ & Stem Cell Transplant
Singapore (PRNewswire): Neovii pharmaceuticals AG of Rapperswil, Switzerland and Mundipharma have entered into an agreement giving Mundipharma the rights to develop and distribute its polyclonal antibody immunosuppressant Grafalon®, in China and Japan from end October. Grafalon® is indicated in solid organ transplant for prevention and treatment of acute rejection, graft-vs-host disease (GvHD) in stem cell transplant (SCT) and in the treatment of aplastic anemia. Grafalon® is the recognised standard of care in leading transplant centers. Under its license, Mundipharma intends to strengthen the distribution and support of Grafalon® in these key markets to advance the clinical development for the prevention of chronic GvHD in SCT. Grafalon® is currently approved for prevention of rejection and the treatment of acute steroid resistant rejection in solid organ transplant in China. Grafalon®, has been used for over 30 years to treat patients, and is currently available in over 50 countries worldwide. Neovii is a global leader in polyclonal antibody immunosuppressive therapy used in organ transplantation and hematology/oncology. Juergen Pohle, Neovii CEO commented, "We are very enthusiastic to work with Mundipharma as a partner to develop Grafalon® in China further by developing its indication for use in stem cell transplantation and further solidifying the position of Grafalon® as a leading treatment for solid organ transplant patients in China." Mundipharma CEO, Raman Singh, said, "We are excited to establish a partnership with Neovii that will have an positive impact on patients in China and Japan, who will have access to the leading technology for prevention of GvHD. "We view Grafalon® as a strategic complement to our existing haemotology and oncology franchise," he added. "SCT continues to be the only curative therapy for many patients with leukemia, lymphoma, and Grafalon® has the potential to help them avoid the debilitating and potentially fatal effects of GvHD."


Abcam Merck Collaboration Produces New PD-L1 Antibody for Immuno-Oncology Research
Cambridge, UK, (B3C newswire): Abcam, a global innovator in life science reagents and tools recently announced the commercial launch of the new anti-PD-L1 antibody clone MKP1A07310 (clone 73-10) developed in collaboration with Merck KGaA, Darmstadt, Germany. Developed by Abcam for use by Merck as an analytical antibody to support Merck’s therapeutic programme several years ago, this new clone has been created by Abcam’s in-house antibody engineers, who specialise in the discovery and development of challenging antibodies. The antibody is important in assessing the expression of PD-L1 in tumors from patients who might be able to benefit from PD-1/PD-L1 checkpoint immunotherapy. John Baker, SVP Portfolio and Business Development, Abcam said: “Collaborations with industry partners are an important part of Abcam’s strategy to provide the best tools to all researchers world-wide. By working with Merck we are able to make available this important antibody at scale to help scientists accelerate their research, and expand understanding of the role of immune checkpoint inhibitors as cancer therapeutics.”


SAI Global and ERM Forge Global Strategic Partnership to Advance Environmental, Health and Safety Innovation
Chicago, (PRNewswire): SAI Global, a leading provider of integrated risk management solutions, and Environmental Resources Management (ERM), the global leader in environmental, health and safety (EHS) consultancy services, have recently announced a strategic partnership to rapidly deploy best in class technology for the EHS market. Through leading risk software, including a comprehensive EHS risk offering, together with ERM's deep domain knowledge and software implementation best practice, the new partnership will provide technology, expertise, and will elevate innovative and best practice EHS solutions delivered to customers. "Our clients trust us to help lead their EHS transformation, and our collaboration with ERM will contribute to our mission to develop real innovation with best practices," said SAI Global CEO Peter Granat. "With this agreement in place our clients will benefit from real expertise, creating time to value and an ecosystem of innovation inclusive of market education, customer experience, and best practices to help them advance confidently and build better EHS outcomes.".


WuXi STA and Antengene Sign Development and Manufacturing Agreement
Shanghai: STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Antengene Corporation, a biopharmaceutical company, recently announced a strategic partnership for the CMC development and manufacturing of innovative oncology drugs. Under the terms of the collaboration, WuXi STA will provide Antengene an integrated solution in process R&D and manufacturing, using the MAH scheme to accelerate new drug development. Antengene is a biopharmaceutical company focused on the development of new drugs in China and the Asia-Pacific region. Through both internal research & development as well as external partnership, Antengene strives to bring cutting-edge innovative therapies to patients. The company’s pipeline includes several clinical-stage drug candidates, covering therapeutic areas from solid tumors, hematologic malignancies to viral infections. WuXi STA was chosen as the strategic partner thanks to its industry leading “end-to-end” CMC platform for new drug development from preclinical to commercial – for both API and finished dosage forms – as well as its expertise and track record for meeting global quality standards. The collaboration will include both clinical stage and commercial projects – starting with Phase II/III candidate ATG-008 and then further expand into three dominant areas such as solid tumor, hematological tumor and viral infection. WuXi STA will provide process R&D and manufacturing from APIs to drug product. Beyond that, Antengene and WuXi STA will also explore expanding the collaboration to commercial stage assets as Antengene prepares for the commercialization of its late-stage pipeline agents. ATG-008 is currently in multi-regional clinical trial (MRCT) for the treatment of hepatitis B virus positive (HBV+) advanced hepatocellular carcinoma (HCC) patients (TORCH study).


ProBioGen and Pionyr Immunotherapeutics Initiate a Second Immuno-Oncology Contract Development and Manufacturing Project
Berlin, Germany, and San Francisco, CA, USA, (B3C newswire): : ProBioGen AG, a premier service and technology provider for complex therapeutic glycoproteins, and Pionyr Immunotherapeutics, an immuno-oncology company which develops next generation antibody-based therapeutics that target the tumor microenvironment, recently announced a second service and license agreement to develop novel antibody therapeutics. Under the terms of the agreement, ProBioGen will perform process development and GMP manufacturing on a second antibody from the Pionyr pipeline using their high performance CHO.RiGHT® expression platform. Parallel cell line development and analysis will allow for optimal cell line selection while compressing the development timeline, enabling a rapid advance to clinical trials. “We developed a strong collaboration with Pionyr Immunotherapeutics on their initial antibody candidate, and we are enthusiastic about advancing a second antibody candidate into development. We consider Pionyr’s Myeloid Tuning™ approach to be ideally suited to target solid tumors and look forward to contributing to multiple programs with our CHO.RiGHT® development and manufacturing platform. We have established a seamless team working across the two companies and are very pleased to expand our collaboration”, said Dr. René Brecht, VP Process Science and Manufacturing.


Immatics Enters into a Strategic Partnership with Genmab to Develop Next Generation Bispecific Cancer Immunotherapies
Tuebingen, Germany, (B3C newswire): Immatics Biotechnologies GmbH, a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting cancer immunotherapies, announced today that it has entered into a research collaboration and license agreement with Genmab A/S (Nasdaq Copenhagen: GEN) to develop next-generation, T-cell engaging bispecific immunotherapies targeting multiple cancer indications. The companies will conduct joint research, funded by Genmab, to combine Immatics’ XPRESIDENT® and Bispecific TCR technology platforms with Genmab’s proprietary antibody technologies to develop multiple bispecific immunotherapies in oncology. The companies will exclusively discover and develop immunotherapies directed against three proprietary targets, which were discovered and developed by Immatics’ XPRESIDENT® technology. Genmab has the option to exclusively license up to two additional targets to expand the partnership at predetermined economics. Genmab will be responsible for development, manufacturing and worldwide commercialization. Immatics will have an option to contribute certain promotion efforts at predetermined levels in selected countries in the EU.


EU and Japan Reinforce Their Collaboration on Inspections of Medicine Manufacturers
London: The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites. The current mutual recognition agreement (MRA) between the EU and Japan has been operational since 29 May 2004. It allows regulators to rely on Good Manufacturing Practice (GMP) inspections in each other’s territories, to waive batch testing of medicines that enter Japan from EU countries and vice versa and to share information on inspections and quality defects. Thanks to this agreement, regulatory authorities in the EU and Japan can make better use of their inspections resources by reducing duplication of inspections in each other’s territory. The scope of this agreement has now been extended to include sterile medicines, certain biological medicines including vaccines and immunologicals, and active pharmaceutical ingredients (APIs) of any medicine covered in the agreement. This means that authorities from the EU and Japan have agreed that they have equivalent regulatory and procedural frameworks for inspections of manufacturers for these products and can therefore rely on each other’s inspections. The full scope of the MRA now covers chemical pharmaceuticals, homeopathic medicinal products (as long as treated as medicinal products and subject to the GMP requirements in Japan), vitamins, minerals and herbal medicines (if considered as medicinal products in both parties); certain biological pharmaceuticals including immunologicals and vaccines, APIs for any of the above categories and sterile products belonging to any of the above categories. In the EU, inspections of manufacturing sites are carried out by national competent authorities from EU Member States. In Japan, GMP inspections are conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) and the 47 inspectorates of the prefectures.


Elekta to Donate Advanced Radiation Therapy Machine to Jordan's Al Bashir Hospital
Stockholm, (PRNewswire): Acknowledging the extra burdens that Jordan's healthcare system faces as a result of the arrival of thousands of citizens from Syria, Elekta has pledged to donate a radiation therapy system (linear accelerator) to Al Bashir Hospital in Amman, Jordan. The linear accelerator - to be delivered later this year – will reinforce Jordan's ability to care for its citizens and for refugees who have or will develop cancer in the coming years. The IAEA, through its Programme of Action for Cancer Therapy (PACT), has helped facilitate the donation, which will complement the long-standing efforts of the IAEA to support Jordan in improving access to quality cancer treatment. "Over many decades Elekta has pursued many radiation oncology projects in Jordan and we have developed a wonderful partnership with clinicians in the country," says Richard Hausmann, Elekta President and CEO.






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