- On 11 February, researchers announced that they had finally sensed the ripples in the structure of space-time known as gravitational waves — capping a decades-long quest.
- A tumultuous US presidential campaign ended in a surprise victory for Republican businessman Donald Trump in November. Researchers struggled to understand how a Trump administration would treat science — in part, because it did not feature prominently on the campaign trail.
- In March, the Japan Aerospace Exploration Agency’s flagship Hitomi X-ray astronomy satellite failed just weeks after launch. Investigators determined that a software error had caused the spacecraft to rotate out of control and break apart. In July, NASA’s Juno probe arrived at Jupiter, but problems with its main engine delayed the rocket firing that would have shrunk its orbit into a tighter ellipse around the planet.
- The development of new applications for the genome-editing tool CRISPR–Cas9 continued apace. On 28 October, a patient with lung cancer at West China Hospital in Chengdu became the first person to be treated with cells edited using CRISPR–Cas9. As part of a clinical trial, researchers disabled a gene that normally holds a cell’s immune system in check, in the hope that the edited cells would mount an immune response against the cancer.
- Representatives of a record 174 countries and the European Union gathered on Earth Day, 22 April, to sign the international climate agreement forged in Paris in December 2015.
- In February, the World Health Organization (WHO) declared that clusters of birth defects linked to outbreaks of Zika virus in Brazil constituted a global public-health emergency.
- In January, a computer program beat a world-class human player at the ancient game of Go for the first time. But the ultimate showdown was in March, when the artificial intelligence (AI), called AlphaGo, trounced Lee Sedol — one of the world’s top players.
- In September, researchers working in a Mexican clinic reported the birth of the first healthy baby conceived through assisted-reproduction techniques that mix DNA from three people. A baby in China was also reportedly born using the same technique. And in October, a clinic in Ukraine announced that two previously infertile women had conceived through a similar procedure. On 15 December, following scientists’ advice, the United Kingdom’s Human Fertilisation and Embryology Authority said that the technique was ready for clinical use, which could start as soon as 2017.
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Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease. The disease has a highly variable course and prognosis. The term lupus has been used to identify a number of chronic, autoimmune diseases that can damage any part of the body (such as skin, joints, and/or organs inside the body). Common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, tiredness, and red rashes commonly on the face. The exact cause for SLE is unknown; however, factors such as sunlight and drugs may precipitate the condition and a complex genetic basis have been identified in many studies.
As reported in many epidemiology based studies, the prevalence of SLE in the population is 20 to 150 cases per 100,000. The prevalence rates vary from 164 (white) to 406 (African American) per 100,000, in women. As per Lupus Foundation of America (LFA), it is estimated that at least 1.5 million Americans have lupus. The exact numbers may vary, as there has not been any large scale study conduducted for SLE in USA. More than 16,000 new cases of lupus are reported annually across the country.
In a most recent event in December 2016, GlaxoSmithKline submitted a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for belimumab, in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE). The New Drug Application (NDA) is based on results from two Phase III studies (Northeast Asia and BLISS-SC) and is seeking MHLW approval for belimumab in two formulations; administration via intravenous infusion and subcutaneous injection.
Generic drugs are dominating the current therapeutic market for lupus disease. Benlysta, a human monoclonal antibody from GlaxoSmithKline is the top-selling medication in the market. The major companies focused on the research and development of therapies for SLE are Roche, UCB, Bristol-Myers Squibb, Anthera, ImmuPharma, Merck Serono, AstraZeneca, Pfizer and GlaxoSmithKline. The pipeline drugs such as Epratuzumab, Anifrolumab and Blisibimod are few late stage emerging therapies being evaluated for the treatment of SLE.
There are many aspects that remain to be elucidated regarding the disease pathogenesis and clinical outcomes. The management of the disease is still a clinical challenge for scientific community due to unexplained aspects of the disease. There is a significant unmet medical need in the field of effective treatments with positive safety profile for better clinical outcomes.
Chronic obstructive pulmonary disease (COPD) is a progressive life-threatening lung disease which leads to airflow limitation and interferes with normal breathing. According to World Health Organization, approximately 64 million people are affected by COPD worldwide. World Health Organization estimates Chronic Obstructive Pulmonary Disease (COPD) to be the fourth commonest cause of death by 2030 after ischemic heart disease, cerebrovascular disease, and HIV/AIDS. Prevalence of COPD is increasing with an increase in ageing population and number of smoking people.
There are approximately 18 drugs such as Advair, Spirivia, Symbicort, Foster, Brovana, Rayos and Bevespi Aerosphere approved for the treatment of COPD. Among them, Advair is a block buster drug with sales of USD 4604.18 million in 2015. Global market of COPD is estimated to increase from USD 11.19 Billion in 2015 to USD 27.89 Billion by 2023. Several factors such as launch of emerging therapies like triple therapies, pharmacogenomic therapy and target lobe volume reduction therapy, increasing prevalence, improvements in diagnostic techniques and advancement of personalized treatments are stimulating the growth of COPD market. Major players such as Medimmune, Astrazeneca, Pearl therapeutics and Cheisi Farmaceutici are developing drugs which are expected to be launch in coming years.
Despite of availability of effective treatment, the prevalence rate of COPD has increased. Currently, approved drugs have limited efficacy with no effects on progression of COPD. Detrimental effects of these anti-inflammatory therapies have been observed among patients. Thus, there is a need of substantial efforts for finding new treatments for COPD.
The only word that described 2016’s pharma M&A market was “slow.” Some do predict that new year—and administration—could revive energy in the deal making arena, the changes might not happen that fast. The reasons are aplenty, as shares have been sagging under the weight of investor fears of drug-pricing reform. Companies aren’t all that keen on putting themselves up for sale while valuations are low. Drug pricing is inhibiting M&A in another way, too. Specialty drug makers have drawn unwanted attention since last summer with their buy-and-hike-prices strategy. In the meantime, they’ve been shying away from the deal making table, fearing they’d become the next Valeant, Turing or Mylan in the spotlight. Thus, the new regime under Donald Trump might blow life into the M&A activities, but this might take time and visible results might take a while.
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For Inflectra launch, Pfizer uses ‘hybrid model’ to home in on HCPs
Pfizer hit the market with Inflectra, a biosimilar of Johnson & Johnson’s Remicade. And with the launch came not only the beginning of a new class of copycats, but a new way to go to market. Each biosimilar, even versions of the same biologic—while required to be “highly similar”—are technically different and come with different datasets and proof points. So, Pfizer went to work to create a new “hybrid model” to bring biosimilars to market. Through this model, each biosimilar brand launch will be customized, each will also leverage the scale of the model platform.
US FDA approves Rubraca to treat advanced ovarian cancer
The US Food and Drug Administration (FDA) has granted approval to Rubraca (rucaparib) for the treatment of advanced ovarian cancer in women. The poly ADP-ribose polymerase (PARP) inhibitor Rubraca is approved for women who have been treated with two or more chemotherapies and whose tumours have BRCA gene mutation as identified by a companion diagnostic test approved by the FDA. Involved with repairing damaged DNA, BRCA genes normally work to prevent tumour development. Mutations of these genes are expected to lead to certain cancers, including ovarian.Rubraca blocks an enzyme involved in repairing damaged DNA.
EMA approves MSD’s PD-1 therapy Keytruda to treat patients with NSCLC
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval of MSD’s Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC). Keytruda is an anti-programmed death-1 (PD-1) therapy that blocks the biological pathways cancers use to disguise themselves from the immune system. The drug has been recommended for patients with NSCLC whose tumours have high PD-L1 expression with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations.
Mylan launches authorized generic version of EpiPen
Mylan has launched the authorized generic version of EpiPen (epinephrine injection, USP) auto-injector, after the recent price hike criticism. The self-injectable device (auto-injector) contains epinephrine, the first-line treatment for life-threatening allergic reactions or anaphylaxis. Expected to reach pharmacies from next week, the authorized generic has the same drug formulation and device functionality as EpiPen auto-injector that is administered in the same way. The authorized generic for EpiPen is available in strengths of 0.15 mg and 0.3 mg.
US drug approvals are on track to drop by more than half in 2016 compared to 2015. The agency had approved 19 new drugs this year as of 9 December, putting it on track for its lowest yearly tally since 2007. The decline is made more dramatic by 2015’s bumper crop of approvals. The FDA approved 45 new drugs last year — the highest total in nearly 20 years. The data come as the agency waits to find out who will be its next commissioner under US president-elect Donald Trump, as he has indicated that he wants to speed up drug approvals and cut through “the red tape at the FDA”. And on 13 December, President Barack Obama signed into law the 21st Century Cures Act, which includes measures intended to streamline drug approvals.
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In United States, Ovarian Cancer has become the leading cause of death in women. Each year approximately 22,280 women are diagnosed with ovarian cancer, and out of those 14,240 die. Women with strong family history of breast cancer or ovarian cancer or who have tested positive for inherited mutation in BRCA1 or BRCA2 genes are often at high risk. Ovarian cancer is touted as “Silent Killer” as the disease progresses before the symptoms are recognized, which include bloating and back pain. In 75 percent of the cases, women do not learn about the disease until the cancer has progressed into stage III.
Treatment options available for treating ovarian cancer include surgery and chemotherapy. In most of the cases, patients respond to first-line chemotherapy; however, 80 percent of the cases show relapse, and more than half of them die within 5 years of diagnosis. Various immunotherapies such as monoclonal antibodies, checkpoint inhibitors and immune modulators, therapeutic vaccines, adoptive T cell transfer, oncolytic viruses and adjuvant immunotherapies are now being developed and are in various clinical phases of development.
Advanced researches are ongoing in top institutions in collaboration with drug developers for more effective and reliable treatment. Recently, researchers at Oxford found a novel target “SIK2”, an enzyme having a role in ‘burning’ fat to produce energy that is needed by the cancer cells to survive in the omentum. SIK2 not only helps ovarian tumors to grow but also supports its development and metastasis. Scientists at The Wistar Institute have discovered a receptor expressed exclusively on ovarian cells, and this discovery may allow them to utilize targeted T-cell technology to potentially eliminate cancerous cells in patients.
These vigorous research and development activities by scientists and drug developers are raising hope for achieving more promising therapeutics for ovarian cancer in the future. Companies like AbbVie (Veliparib), Tesaro (Niraparib), AstraZeneca (Cediranib), Novartis (Pazopanib), and CTI BioPharma (Paclitaxel Poliglumex) have progressed their lead compounds in highest stage of clinical development. Over 200 drugs are in pipeline for the treatment of ovarian cancer out of which nearly half of them had entered clinical stage of development.