In March, just one month after Merck introduced its new insomnia drug, Belsomra, physicians were writing 4,000 prescriptions a week for the new product—enough for CEO Kenneth Frazier to declare the launch a success during the company’s first-quarter earnings call. Excitement over the Belsomra is so high, in fact, that U.K.-based consulting firm GlobalData predicts […]
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
Current health systems built to evaluate and pay for traditional drugs are going to struggle with gene and other unusual therapies – but manufacturers can take steps before launch to define how manufacturers assess and value these new products.
This yearly review analyzes recent developments, trends and outlooks in the areas of biotechnology, biosimilars, biopharmaceuticals, biologics, biomarkers and biobanks.
A recent study of DTC advertising appearing in the Journal of General Internal Medicine concluded that few broadcast ads are compliant with FDA’s guidelines. The reality, though, might not be so cut and dried.
As more innovative – yet even more expensive – therapies enter the U.S. market, brand marketers will have to find equally new and innovative ways to prove the value of their medicines to payers and patients, especially as insurance plans continue to put more of the cost burden on patients.
On Oct. 28, 2016, my mother, Joan Biamonte, died of complications from metastatic carcinoma of the lung. Despite having her original tumor characterized and going through a regimen of chemotherapy allegedly tailored to her tumor type, her cancer proliferated and spread into her liver and brain.
The Cancer Immunotherapy Market Will Capture Major-Market Sales of Over $13 Billion In 2023 and Will be Dominated by Immune Checkpoint Inhibitors
BURLINGTON, Mass., June 4, 2015 /PRNewswire/ — Decision Resources Group finds that the cancer immunotherapy market will experience an impressive 29% annual growth over the forecast period and will reach $13.3 billion in 2023 across the seven major markets (United States, France, Germany, Italy, Spain, United Kingdom and Japan). Growth will be fuelled by successive label […]
Drugmakers including Bristol-Myers Squibb Co and Merck & Co are testing which patients will most benefit from new cancer treatments based on a protein found in their tumors, but that guide, known as a biomarker, may be too unreliable, researchers and health experts said. Bristol’s Opdivo and Merck’s Keytruda are both therapies designed to block […]
The National Cancer Institute in July will start enrolling patients in a clinical trial seeking to match the underlying genetic defect driving a person’s tumor with one or more of 20 approved or experimental drugs targeting that gene. The announcement, made at the American Society for Clinical Oncology meeting on Monday, is meant to use […]
The head of Merck KGaA’s healthcare division said she expected its cancer drug avelumab, jointly developed with Pfizer, to be among the first two or three to market in a field of immunotherapy pharmaceuticals that harness the power of the immune system in a range of cancer types. Other developers of immunotherapy drugs have won […]
The promise of cancer drug R&D has been on display these past few days at the American Society of Clinical Oncology (ASCO) meeting in Chicago. Breakthroughs abound with a good deal of attention being focused on immuno-oncology drugs that enhance the immune system to combat various forms of cancer. Of particular interest are the “checkpoint […]
Those with a vested interest in the development of new cancer therapies have been spoiled once again by data presented at the ongoing annual meeting of the American Society of Clinical Oncology (ASCO). For the third year in a row, immuno-oncology treatments – particularly the PD-1/PD-L1 inhibitors – have dominated headlines. With ASCO providing the […]
Combination of Novartis drugs Tafinlar and Mekinist shows significant survival benefit in patients with metastatic melanoma
EAST HANOVER, N.J., May 31, 2015 /PRNewswire/ — Novartis today announced data from the Phase III COMBI-d study showing a significant survival benefit for patients with BRAF V600E/K mutation-positive metastatic melanoma when treated with the combination of Tafinlar® (dabrafenib) and Mekinist® (trametinib) compared to Tafinlar monotherapy alone. This is the first combination of BRAF/MEK inhibitors […]
ASCO 2015: Superior overall survival for afatinib compared to erlotinib demonstrated in head-to-head trial in patients with previously treated advanced squamous cell carcinoma of the lung
RIDGEFIELD, Conn., May 31, 2015 /PRNewswire/ — Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly […]
A new cancer treatment from Bristol-Myers Squibb saved Gary McLaughlin’s life, but it also landed him in the hospital. McLaughlin, 75, developed melanoma, the deadly skin cancer, just as he was retiring for real. He’d quit his job as a hospital administrator at 70, but spent two years helping his wife run her quilting store before […]
Patients with colon and other cancers who have a specific defect in genes needed for DNA repair are far more likely to respond to a new class of drugs such as Merck & Co’s Keytruda, which enlist the immune system to attack tumors, a new study has shown. The small study, financed not by Big […]
A Merck & Co drug that helps the immune system fight cancer was about twice as effective as the current standard therapy for patients with recurrent or advanced head and neck cancers, according to study data released on Friday. A quarter of the 132 patients who received the drug, Keytruda (pembrolizumab), saw their tumors shrink […]
Bristol-Myers Squibb Co’s drug, Opdivo, improved survival for patients with the most common form of lung cancer, nearly doubling survival for those with high levels of a specific protein in their tumors compared with chemotherapy, according to clinical trial results presented on Friday. The trial found that Opdivo, part of a new class of drugs […]
AstraZeneca and Eli Lilly are to combine two of their cancer drugs in a new clinical trial against solid tumors in the latest sign that such cocktails may be the way forward in fighting the disease. AstraZeneca’s experimental anti-PD-L1 immunotherapy drug MEDI4736 will be tested alongside Lilly’s approved medicine Cyramza, or ramucirumab, the two […]
Salix Announces FDA Approval of Xifaxan® 550 mg for the Treatment of IBS-D (Irritable Bowel Syndrome with Diarrhea)
Xifaxan® 550 mg is the first-and-only nonsystemic antibiotic approved for the treatment of IBS-D in adults LAVAL, Quebec, May 27, 2015 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for Xifaxan® 550 mg for […]
FTC Settlement of Cephalon Pay for Delay Case Ensures $1.2 Billion in Ill-Gotten Gains Relinquished; Refunds Will Go To Purchasers Affected By Anticompetitive Tactics
WASHINGTON, May 28, 2015 /PRNewswire-USNewswire/ — The Federal Trade Commission has reached a settlement resolving the Commission’s antitrust suit charging Cephalon, Inc. with illegally blocking generic competition to its blockbuster sleep-disorder drug Provigil. The settlement ensures that Teva Pharmaceutical Industries, Ltd., which acquired Cephalon in 2012, will make a total of $1.2 billion available to […]
Otsuka Pharmaceutical Co Ltd has lost a lawsuit challenging the U.S. Food and Drug Administration’s decision to allow generic versions of the company’s antipsychotic drug Abilify. At the end of April, the FDA approved applications to make Abilify by several generic drugmakers, including Teva Pharmaceutical Industries Ltd, which immediately announced it would launch its own […]
Pharma companies have long demonstrated that they will employ questionable marketing and sales tactics to boost sales, no matter what the impact is on patients’ health. Now Amarin, a small drug maker that sells the prescription drug Vascepa, hopes to bolster its bottom line by suing the Food and Drug Administration, claiming that the company’s […]
Amarin Granted Summary Judgment Motion in Suit Against FDA Seeking New Chemical Entity Market Exclusivity for Vascepa(R) (Icosapent Ethyl) Capsules
BEDMINSTER, NJ and DUBLIN, IRELAND–(Marketwired – May 28, 2015) – Amarin Corporation plc (NASDAQ: AMRN), announced today that Judge Randolph D. Moss of the federal district court for the District of Columbia has granted Amarin’s motion for summary judgment in the company’s lawsuit against the United States Food and Drug Administration (FDA) seeking an order […]
New data to be released this weekend should help deepen the understanding of how broadly new drugs that unleash the body’s immune system to fight cancer can be used. Results from key clinical trials will be presented starting Friday in Chicago at the annual meeting of the American Society of Clinical Oncology. These will include […]