CognitrexCancerDigest

Pharmaceutical company Biocon has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients a variety of cancers in India. The biosimilar — or a drug that mimics a natural protein — is useful in treating metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers. It will be priced at Rs 24,000 for 100 mg/4 ml vials and Rs 39,990 for 400 mg/16 ml vials, making it a high quality affordable alternative to the innovator brand, the company said. KRABEVA is the second key oncologic biosimilar product from Biocon’s global biosimilars portfolio to be launched in India. This will provide a “a world class, high quality biosimilar Bevacizumab for cancer patients in India,” the company said. Bevacizumab is indicated as a first-line treatment of patients with metastatic colorectal cancer (mCRC), and is accepted as a standard treatment option in combination with chemotherapy for patients with non-small-cell lung cancer (NSLC), m...

Johnson & Johnson's blockbuster multiple myeloma drug  Darzalex  when added to a standard therapy regimen reduced the risk of disease progression or death by 50 percent compared with the standard therapy alone in patients not previously treated for the blood cancer, according to data released on Tuesday. The data could lead to approval of the Darzalex combination as an initial, or first-line, therapy for multiple myeloma, providing a larger sales opportunity for the medicine, one of J&J's most important growth drivers. Darzalex, a biotech drug known chemically as daratumumab, is already approved in combination with other medicines or alone in patients who had received one or more prior treatment regimens. It had third quarter sales of $317 million, with annual sales forecast to reach about $5 billion by 2021, according to Thomson Reuters data. In the first-line study, 706 patients deemed not eligible for bone marrow transplant received either Darzalex with Ta...

The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy). Adjuvant treatment is a form of therapy that is taken after an initial surgical removal to lower the risk of the cancer coming back. “This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with this disease who have a nephrectomy are often at high risk of the cancer returning,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “There is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence.” The National Cancer Institute (NCI) at the National Institutes of Health e...

Biotech companies are competing to develop medicines using "bugs as drugs" to fight cancer, building on the latest scientific findings that patients with high levels of good gut bacteria are more likely to respond to modern immunotherapy. Certain bacteria seem to help in cancer by priming immune cells and smoothing the path for immunotherapy drugs known as PD-1 drugs that work by taking the brakes off the immune system. Seres Therapeutics hopes to become the first company to leverage this discovery through a collaboration with the MD Anderson Cancer Center in Texas and the Parker Institute for Cancer Immunotherapy that will see its microbe medicine tested in a clinical trial. The Cambridge, Massachusetts-based firm has an exclusive option to license patent rights under the deal announced on Tuesday. MD Anderson scientists were among two groups of cancer researchers who reported on the benefits of good gut microbes in the journal Science earlier this month. The work under...

Bhubaneshwar: American Oncology Institute (AOI), a Hyderabad-based chain of cancer hospitals founded by a team of leading oncologists at the University of Pittsburgh Medical Centre in USA, today commenced operations in Bhubaneswar in collaboration with Sparsh Hospitals & Critical Care.The dedicated cancer treatment and diagnostic center will provide advanced medical oncology and surgical oncology services for all types of cancers for all age groups. The facility comes up at a time when cancer incidences in the state of Odisha are on the rise due to use of tobacco and tobacco products, ageing population, unhealthy life styles and lack of awareness about early detection. Services offered at the center will include Medical Oncology and Surgical Oncology specialties. AOI and Sparsh Hospitals is also in the process of setting-up a brand-new state-of-the-art-facility in Bhubaneswar with 300+ beds offering comprehensive cancer care including Radiation oncology. AOI was started with an a...

The delegation, identified by Healthcare UK as some of the UK’s most innovative in oncology healthcare, will attend the 2nd Indian Cancer Congress in Bengaluru from 9 to 12 November. They will also visit the India-UK Healthcare Forum 2017 in Mumbai on 13 November. India is expected to see 1.73 million new cancer cases by 2020 (source: National Cancer Registry). Oral, breast, lung, cervical cancers are among the leading causes of deaths in the country. India requires new technology in every aspect of this disease - from genetics to early detection, new treatment protocols and medical equipment. India and the UK share common goals with regard to cancer treatment and research. The UK is at the forefront of cancer research, as well as the development and introduction of new technologies. The UK’s National Health Service ( NHS ) has a cancer strategy to improve cancer prevention, diagnosis, treatment and end-of-life care. The  NHS  and UK companies have compelling offers in...

Biotechs are attracting multi-million dollar investments to pioneer new cancer treatments. Puma Biotechnology  this week announced it had secured a loan facility of up to $100 million – from the Silicon Valley Bank and Oxford Finance – to support the commercialisation of its NERLYNX® therapy, for early-stage breast cancer. It is given to improve the chances a cancer won’t return – after a patient has received an initial treatment. The U.S. Food and Drug Administration (FDA)  approved NERLYNX®  in July. Dr Richard Pazdur, Director of the FDA’s Oncology Center of Excellence, saying it had demonstrated it “may help keep the cancer from coming back”. “We’re proud to support Puma as they work to reduce the risk of breast cancer recurrence and develop novel therapies for the treatment of cancer. It’s our pleasure to arrange this financing for Puma as they commercialize NERLYNX and endeavor to bring this impactful therapy to patients through...

GlaxoSmithKline received a boost for its  oncology research  on Thursday when an experimental drug for  blood cancer received a "breakthrough" designation from U.S. regulators. The decision by the Food and Drug Administration paves the way for a speedy regulatory review of the BCMA drug for  multiple myeloma . It follows similar priority treatment granted by the European Medicines Agency last month. Although  GSK  sold its marketed cancer drugs to Novartis in 2015, it continues to invest in early-stage research and has said oncology could become another pillar of its pharmaceuticals business, alongside HIV and respiratory medicine. The actions by the U.S. and European regulators are based on promising Phase I clinical trial results, details of which will be announced on Dec. 11 at the annual meeting of the American Society of Hematology meeting in Atlanta. GSK said it planned a rapid programme of clinical trials with the new drug, both alone and i...

 The Securities Appellate Tribunal has asked Sebi to expeditiously pass a fresh order in the matter relating to Diageo Plc requiring to make additional payments to the minority shareholders of United Spirits Ltd. Diageo became a controlling shareholder of USL -- whose erstwhile promoter was now fugitive liquor baron Vijay Mallya -- in May 2013 with 25.02 per cent stake after completion of a Rs 3,134.56 crore open offer. Later in June 2016, markets regulator Sebi through a notice told Diageo that the company might have to make additional payments to the minority shareholders of USL on the basis of Diageo's Watson backstop guarantee agreements for Watson Ltd, a company affiliated to Mallya. Sebi's decision was challenged before the Securities Appellate Tribunal (SAT) with Diageo contesting that the notice was misconceived and wrong in law. "... We direct that the impugned communication dated June 16, 2016 be treated as a supplementary show cause notice issued to th...

The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.” Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma and, according to the National Cancer Institute at the National Institutes of Health, represents 3 to 10 percent of all non-Hodgkin lymphoma cases in the U.S. Mantle cell lymphoma is a cancer of the lymph system, which is part of the body’s immune system and is made ...

A setback for Merck & Co's key cancer drug sent the drugmaker's stock swooning on Monday for a second straight session, putting the shares on track for their biggest two-day decline in more than eight years. Late on Friday, Merck withdrew an application for European use of its flagship drug Keytruda as an initial, or first-line, treatment for advanced lung cancer in combination with chemotherapy, raising questions about future sales. The Keytruda/chemo combination is already approved in the United States based on initial promising data. But the company determined that a similar European first-line approval without more mature late-stage data was unlikely. Lung cancer is by far the most lucrative oncology market with first-line approval providing access to the most patients. In the wake of the news, at least three analysts cut their ratings on Merck's stock, a component of the blue-chip Dow Jones Industrial Average, while other analysts lowered their target pri...

Novartis  has agreed to buy French-based  Advanced Accelerator Applications  (AAA) for $3.9 billion, giving it a platform in  radiopharmaceuticals  and access to a new therapy for the kind of cancer that killed Steve Jobs. The deal further strengthens the Swiss drugmaker's  oncology business, already boosted by the 2015 acquisition of GlaxoSmithKline's marketed  cancer drugs  and August's approval of a ground-breaking gene-modifying leukaemia treatment. The cash offer of $41 per ordinary share and $82 per American depositary share represents a 47 percent premium to AAA's price before media reports on Sept. 27 that Novartis was interested, the two companies said on Monday. The ADS, which closed on Friday at $72.91 and were priced at only $16 when they listed two years ago, traded at $80 in U.S. premarket dealings. The transaction, which Novartis is to finance using debt, will reap AAA founder and 11 percent owner Stefano Buono more than $...