AstraZeneca announces availability of Saxa / Dapa FDC in UK

UK-based AstraZeneca has announced the availability of Qtern for adult patients with type 2 diabetes in the country. Quern is a fixed dose combination of saxagliptin and dapagliflozin. The tablet received marketing authorization from the European Commission on 19 July last year and is indicated in adults aged 18 and older with type 2 diabetes in order to improve glycemic control. The European Commission approved the tablet based on data from three Phase III randomised.

Saxa / dapa FDC can be used in patients with mild renal impairment and should be avoided in patients with moderate-to-severe renal impairment.

Trivitron launches its digital radiography system Ultisys at Arab Health 2017

Trivitron Healthcare’s radiology division Kiran Medical Systems has now introduced its innovation driven Ultisys range of radiography products during the Arab Health Convention in Dubai. Ultisys offers an affordable yet versatile platform for a wide range of clinical applications involving general radiography.

Kiran’s portfolio of radiology products includes the Infinity and Elite series surgical C-Arm systems available in 3.5kW and 5.0kW power output and the option of 1Kx1K digital imaging chain with advanced image processing capabilities.

BrainStorm Cell Therapeutics validates NurOwn Cryopreservation

Brainstorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that it has validated its cryopreservation process for NurOwn in preparation for the upcoming phase 3 clinical study in amyotrophic lateral sclerosis (ALS).

The validation involved a comparison of NurOwn (MSC-NTF cells) derived from fresh mesenchyme stem cells (MSC) to those derived from cryopreserved MSC.  Company scientists were successful in showing that the MSC can be stored in the vapour phase of liquid nitrogen for prolonged periods of time while maintaining their characteristics.

NEI scientists identify stem cell secretions may protect against glaucoma

A new study in rats shows that stem cell secretions, called exosomes, appear to protect cells in the retina, the light-sensitive tissue in the back of the eye. The findings, published in Stem Cells Translational Medicine, point to potential therapies for glaucoma, a leading cause of blindness in the United States. The study was conducted by researchers at the National Eye Institute (NEI), part of the National Institutes of Health (NIH).

Follicle Stimulating Hormone in Endometriosis

Follicle Stimulating Hormone (FSH) is a glycoprotein secreted by the anterior pituitary, necessary for mammalian reproduction. FSH helps in development and maturation of gonads at puberty, and the hormone acts by binding to FSH receptor. Endometriosis is an extra growth of endometrial tissues in the abdominal cavity. As Follicle-stimulating hormone receptor (FSHR) is present on endothelial cells of blood vessels and endometrial glands of the proliferative and secretory endometrium, FSH therapy can be very helpful in curing endometriosis.

Some of the therapies for endometriosis treatment include non-steroidal anti-inflammatory drugs (NSAIDs), progestins (medroxyprogesterone), a combination of estrogens and progestins, synthetic androgens (danazol), and gonadotropin-releasing hormone analogues with or without hormone replacement therapy and many more. Other therapies include transcutaneous electrical nerve stimulation (TENS) may be effective for the treatment of women with deep endometriosis.

For treating endometriosis, various hormonal therapies are in the market, by different companies like Teva Pharmaceuticals, Healthcare Pharmaceuticals, and Bayer. Teva has launched a drug named as Sprintec; Dienogest is marketed by Bayer HealthCare Pharmaceuticals and is considered as long term treatment for Endometriosis when administered properly.

Bayer is also in progress of developing 4 more therapies for endometriosis, out of which one relates to FSH therapy. Other companies like Abbvie (Elagolix- Phase III) and Takeda Pharmaceuticals (TAK-385; relugolix- Phase IIb) are in progress of developing appropriate hormone therapy or drug for treating Endometriosis. The field for endometriosis medicinal therapies is progressing rapidly and with the ongoing development of drugs and therapies for its treatment, the market for endometriosis treatment is on the verge of flourishing very soon in a very positive manner.

Insight by:

Neha Chaudhary
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business and facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutical indications. Delveinsight has a database of 3000+ high-quality analytical reports

The Business Cocktail

Payers block Kaléo’s expensive EpiPen challenger

Kaléo reintroduced its Auvi-Q last week at a list price of $4,500 for a two-pack in an effort to capture some market share from Mylan’s EpiPen, which is listed at about $600 for a two-pack. Auvi-Q is set to launch next month. Under Kaléo’s pricing strategy, Auvi-Q will cost most patients $0 out-of-pocket. If an insurer refuses to cover the med, the company will step in and pay for that access, execs said last week. Uninsured patients can purchase the drug at a cash price of $360 for a two-pack. Instead, the strategy shifts the costs to insurers and pharmacy benefit managers. At a list price multiples higher than its competition, Kaléo Pharma’s revived Auvi-Q has hit resistance from some of the nation’s top pharmacy benefit managers and insurers. Cigna has said no to the idea, while Humana is not talking to the company and Aetna is restricting its product for now.

FTC settlement clears Endo from pay-for-delay liability; Watson, Allergan charged

According to the FTC complaint, Lidoderm was an important product for Endo back in 2011. That year, the company made $825 million in sales off the lidocaine patch, or 30% of its annual sales haul, meaning generic competition would pose “significant financial risks” to the company. Endo paid Watson at least $250 million to delay that competition, according to the feds. Through an “administrative complaint,” authorities are also going after Impax Laboratories, which they say received $112 million back in 2010 to delay a generic competitor to Endo’s Opana ER. Endo International has pledged to swear off pay-for-delay agreements. But even as the government moves to wrap up its case against Endo, authorities continue to pursue claims against Watson and Allergan.

Amgen hikes prices by single digits, with Enbrel matching AbbVie’s Humira boost

Amgen raised the price of its top-selling med, Enbrel, an 8.4% hike that followed a larger one just six months ago. It also came on the heels of an identical price hike for one of Enbrel’s key competitors, AbbVie’s Humira. Amgen executives say payer discounts will eat up most if not all of its latest hikes. The move follows a 28% increase for the anti-TNF blockbuster in 2015 and another boost of 9.9% in July 2016. During Amgen’s third-quarter 2016 conference call, commercial operations head Anthony Hooper said the company expects “relatively little benefit” on Amgen price changes in 2017 due to competitive payer negotiations.

Baxter paying $18M to settle federal case over sterile plant failings

Ignoring issues in a sterile manufacturing plant can lead to big problems, like FDA warning letters, which Baxter International received for a plant in North Carolina after mold was found in HEPA filters. But in rare cases, it can lead to even more severe penalties, like the $18 million-plus Baxter will pay to resolve a federal criminal case, as well as a civil matter brought by a whistleblower over the mold concerns.  Baxter will pay another $2.158 million to resolve a civil whistleblower case brought by Baxter employee Christopher Wall who had reported to the mold problem to plant management. Wall’s case alleged his concerns were overlooked and the plant continued to manufacture and sell product from the facility. Wall gets $431,535.99 as his share of the settlement.

The Snippet : Sub types of cervical cancer identified

Cervical cancer remains one of the leading causes of cancer-related deaths worldwide. A recent publication in nature reported the extensive molecular characterization of 228 primary cervical cancers, and has been dubbed as the largest comprehensive genomic study of cervical cancer to date. The authors observed striking APOBEC mutagenesis patterns and identified SHKBP1, ERBB3, CASP8, HLA-A, and TGFBR2 as novel significantly mutated genes in cervical cancer. They also discovered novel amplifications in immune targets CD274/PD-L1 and PDCD1LG2/PD-L2, and the BCAR4 lncRNA that has been associated with response to lapatinib. The authors were also able to identify a unique set of endometrial-like cervical cancers, comprised predominantly of HPV-negative tumors with high frequencies of KRAS, ARID1A, and PTEN mutations. Integrative clustering of 178 samples identified Keratin-low Squamous, Keratin-high Squamous, and Adenocarcinoma-rich subgroups. These molecular analyses, thus, revealed new potential therapeutic targets for cervical cancers.

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U.K. weighs drug rationing as NHS England’s budget tightens: report

Patients in the U.K. face yet another barrier to access as a tough budget situation has forced the country’s healthcare system to consider rationing costly drugs. Among them are medicines from Johnson & Johnson, Merck and Roche. Beginning in April, cancer patients and others could have to line up for medicines that cost NHS England more than £20 million per year, The Times reported. That’s even after those meds have been deemed cost-effective by the National Institute for Health and Care Excellence (NICE). The move comes at a troublesome time at NHS, as its chief executive, Simon Stevens, said publicly this month that Prime Minister Theresa May was “stretching the truth” about the agency’s budget. He said NHS received “less than we asked for” from the British government.

Applying Digital Technologies to Profit from Change in the Pharma Industry

Pharmaceutical companies are increasingly challenged to keep pace with the evolving demands of patients, physicians and payers. Patients are increasingly seeking higher levels of involvement and understanding of their own treatment plans. In fact, a recent survey found that more than 85% of patients are confident in their ability to take responsibility for their health and knew where to access online resources to do so. Much of this information is sought after via mobile devices: over 60% of smartphone users use their mobile devices to search for information regarding a health condition. Furthermore, patients are increasingly favoring third party sites where they can obtain syndicated information on health conditions and related treatments.

Drugmakers ‘hijacked’ the FDA’s orphan system to score premium pricing on mass-market meds

There’s no denying that financial incentives for orphan drug development saved hundreds of thousands of lives. But they’ve also helped mass-market drug makers rack up millions in incentives, tax breaks and patent-protected profit. According to a report, About one-third of the orphan drug approvals since the program began have been for repurposed, large-market products or drugs with multiple orphan green lights. Best-sellers such as Crestor from AstraZeneca, Abilify from Otsuka, Herceptin from Roche and Humira from AbbVie fall into the category of big sellers whose makers snagged millions in government incentives—not to mention seven years of exclusive rights on the market—when they resubmitted their therapies as treatments for smaller populations. Others, such as Allergan blockbuster Botox, started out as small-market meds and proceeded to collect multiple orphan approvals.

FDA slaps Florida blow-seal-fill facility with warning letter

The FDA has come down on an aseptic blow-fill-seal pharma manufacturing operating in Florida that the agency says has widespread issues with microbiological contamination. The FDA posted a warning letter that was issued last month to Horizon Pharmaceuticals following an inspection that dates back to the fall of 2015. The FDA said that when it inspected the company’s facility in Riviera Beach, Florida, it “found multiple deficient practices at (the) facility that pose a significant microbiological contamination risk.” Among those was its cleaning and disinfection program, which it said didn’t use a sporicidal agent. The inspectors discovered the facility had shipped three lots of an ophthalmic drug even though some bottles which were tested were contaminated with Bacillus mycoides, which is a spore-forming microbe.

Cytomegalovirus (CMV) infection: Market Outlook

Cytomegalovirus (CMV) infection is a major Herpes virus infection, which is the leading cause of morbidity and mortality worldwide among congenitally infected newborns, HIV/AIDS patients and transplant recipients. According to Centers for Disease Control and Prevention, approximately 80,000 cases of CMV infections are found in United States and Europe. High prevalence of Cytomegalovirus (CMV) infection is found in developing countries and in areas of lower socioeconomic conditions.

In terms of treatment scenario, several drugs such as Valganciclovir (Valcyte), Foscarnet (Foscavir), Cidofovir (Vistide) are approved and marketed. Valtrex and Cytotect are approved for Cytomegalovirus (CMV) infection, and Valganciclovir or Ganciclovir are used as first-line treatment. Additionally, Foscavir is used as second-line therapy for patients who do not respond to Ganciclovir treatment. Lastly, Cidofovir is used as an alternative therapy among those patients who do not respond to Ganciclovir and Foscarnet treatment. The current market of CMV infection is weak due to presence of several generics, such as Ganciclovir and Foscarnet, and patent expiry of marketed drugs.

Due to increasing awareness related to herpes virus infections, improvement in healthcare infrastructure, increase in number of patients undergoing transplantation, government support and increase in prevalence of CMV infection, there is a hope for the Global market size of CMV infection to increase from USD 698.3 Million in 2013 to USD 1,210.4 Million by end of year 2023. Prophylactic and therapeutic market size is expected to grow at a CAGR of 6.57% and 3.44% respectively, during 2013-2023. Major players such as Merck & Co., Chimerix Inc, Astellas Pharma and CSL Behring are developing drugs which are expected to be launched in coming years. These emerging therapies have better efficacy and safety profiles as compared to the existing therapies. Launch of emerging therapies such as Letermovir and TransVax in coming years may also stimulate growth of the CMV market. Also, companies are focusing on developing drugs with novel mechanisms of action beyond DNA polymerase inhibitors, which may provide a stiff competition to the existing therapies.

Insight by:
Diksha Wadhwa
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business and facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutical indications. Delveinsight has a database of 3000+ high-quality analytical reports.

Fragile X syndrome (Martin-Bell syndrome): X-linked mental retardation and macroorchidism

Fragile X syndrome (FXS) is an inherited genetic condition that causes mental retardation, intellectual disability, and autism. Etiology of the disease includes the defect in the FMR1 gene located on the X-chromosome, which prevents the gene from properly synthesising a protein called the fragile X mental retardation 1 protein. Lack of this protein causes symptoms characteristic of FXS, although the exact function of this protein is not fully known.

FXS is more common in males, and usually, have more severe symptoms than in females. Studies suggest that the condition affects 1 in 4,000 males, whereas in females, it affects about 1 in every 8,000. The prevalence of female carrier status has been estimated to be as high as 1 in 130-250 and that for the male it is estimated to be 1 in 250-800.

Major players in this field are pharma giants such as Novartis Pharmaceuticals and Hoffmann-La Roche along with some mid-level to small pharmaceutical companies like Neuropharm, Seaside Therapeutics and Alcobra. Recently, in January 2017, Marinus Pharmaceuticals reported that the FDA has granted Orphan Drug Designation to ganaxolone to treat patients with fragile X syndrome and Zynerba Pharmaceuticals has started an exploratory phase 2 clinical trial of ZYN002 cannabidiol (CBD) topical gel in children with FXS. In a less exciting event that took place in January 2017, MDX (by Alcobra) is being evaluated for use in FXS, has already hit a few roadblocks. The U.S. Food and Drug Administration recommended Alcobra to conduct a new MDX trial to expel safety concerns emanating from preclinical data.

Various studies have indicated a wide range of unmet medical needs in people with FXS. Currently, there are no drugs approved for FXS and a few drugs in clinical development. The development of personalised medicine and targeted therapeutics for neurodevelopment disorders represents an unmet medical need for FXS. In current trends, there are medications available for symptom-based treatments. Current trends in treating FXS include medications only for symptom-based treatments that aim to minimise the secondary characteristics associated with the disorder.

Insight By:
Mohammad Rizwan
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business and facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutical indications. Delveinsight has a database of 3000+ high-quality analytical reports.

The Business Cocktail

With Flublok at a standstill in Japan, Astellas ditches collaborator UMN Pharma

After Japanese regulators turned away the partners’ submission for a new cell-culture flu vaccine, Astellas has pulled the plug on a collaboration with UMN Pharma. UMN said it’s “regrettable” the companies can no longer work together to push the vaccine, Protein Sciences’ Flublok, to the market in Japan. The pharmas first linked up back in 2010. The shot had previously met its endpoints in a phase 3 trial, according to a release from UMN, and development partner Astellas submitted a marketing application to Japanese health authorities in May 2014. The Pharmaceuticals and Medical Devices Agency considered the risks and benefits, and notified Astellas that it would not further conduct its review; Astellas moved to withdraw the app.

Deal-talkers J&J, Actelion reportedly land on a price, but spinoff details still pending

Johnson & Johnson and Actelion may have finally settled a key condition of their long-discussed transaction. The pair has landed on a price for the deal, although sources didn’t tell what that price was. J&J was considering a price in the $260-per-share range for Actelion’s marketed meds, a figure that would bring the buy to more than $28 billion. J&J’s courtship of the Swiss biotech has been a long one, in part thanks to Actelion founder and CEO Jean-Paul Clozel’s desire to keep a piece of his company flying solo.

To win Trump’s deal backing, Bayer made a new $8B-plus pledge.

Bayer’s $66 billion Monsanto takeover has plenty of critics. But thanks to an $8 billion R&D pledge, it has one key backer: U.S. President-elect Donald Trump. Bayer and Monsanto said that their respective CEOs—Werner Baumann and Hugh Grant—had a “very productive” meeting with Trump and his team, resulting in a pledge to promise $16 billion or more in agriculture R&D over the next six years, with at least half of that coming in the U.S.

Biogen to fork over $1.25B-plus to settle blockbuster Tecfidera patent fight with Forward

Biogen has settled its Tecfidera patent fight with Forward Pharma for a whopping $1.25 billion in upfront cash. And if Forward wins particular patent rights on its rival drug, Biogen will be on the hook for Tecfidera royalties of at least 10%. Forward shares skyrocketed 83% to a $33.28 high in premarket trading on Tuesday after Biogen announced the deal. Although the companies still have issues to resolve, the agreement gives Biogen a license to all of Forward’s related intellectual property, and it grants the Danish company potential royalties on Tecfidera, a product that brought in nearly $2.4 billion in sales in the first nine months of 2016 alone. Forward is developing a potential Tecfidera competitor now dubbed FP187.